Document text
Page 1 of 524
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE
3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968177
Page 2 of 524
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/25/2020
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968178
Page 3 of 524
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10891182]
2.Birth Date: /1973
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0968179
Page 4 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968180
Page 5 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968181
Page 6 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968182
Page 7 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[penicillin drug allergy]
Start Date: Unknown
//Comments
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[amoxicillin drug allergy]
Start Date: Unknown
//Comments
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[codeine drug allergy]
Start Date: Unknown
//Comments
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[erythromycin drug allergy]
Start Date: Unknown
//Comments
Ongoing: YES
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968183
Page 8 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[beans food allergy]
Start Date: Unknown
//Comments
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[schizophrenia]
Start Date: Nov/3/2017
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[COPD]
Start Date: Dec/17/2014
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Polysubstance Abuse]
Start Date: Aug/17/2018
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Atrial Fibrillation]
Start Date: Unknown
//Comments
Ongoing: YES
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968184
Page 9 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seizure disorder]
Start Date: Unknown
//Comments
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[funnel chest]
Start Date: Unknown
//Comments
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: Unknown
//Comments
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[asthma]
Start Date: Unknown
//Comments
Ongoing: YES
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968185
Page 10 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PTSD]
Start Date: Not Applicable
//Comments
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[borderline personality disorder]
Start Date: UNK/UNK/2014
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[arthritis]
Start Date: Unknown
//Comments
Ongoing: YES
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[stroke]
Start Date: Unknown
//Comments
Ongoing: Unknown Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968186
Page 11 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left hand fracture]
Start Date: Aug/12/2020
Ongoing: NO
End Date:
Aug/24/2020
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[skin rash]
Start Date: Jul/27/2020
Ongoing: YES
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Lymph node biopsy]
Start Date: Unknown
//Comments
Ongoing: Unknown Comments
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[undescended testicle right]
Start Date: Unknown
//Comments
Ongoing: Unknown Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968187
Page 12 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hernia repair]
Start Date: Unknown
//Comments
Ongoing: Unknown Comments
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[abdominal surgery]
Start Date: Unknown
//Comments
Ongoing: Unknown Comments
1.xLine/MH Number: [24]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[testicle exploration right]
Start Date: Unknown
//Comments
Ongoing: Unknown Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968188
Page 13 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
2.Weight: [150.2]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [23.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968189
Page 14 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/25/2020
2.Randomization Number: [65233]
3.Randomization Group: [ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968190
Page 15 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNW63J]
5.bSample ID [BNW63K]
5.cSample ID [BPYHJ2]
5.dSample ID [BPYHJ3]
5.eSample ID [BPYHJ4]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968191
Page 16 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3PMW]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968192
Page 17 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/25/2020 14:22
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968193
Page 18 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968194
Page 19 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968195
Page 20 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Temperature: Not Done
[ ]Comments
Unit: Not Done Comments
Temperature Location: Not Done Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968196
Page 21 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968197
Page 22 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968198
Page 23 of 524
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968199
Page 24 of 524
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968200
Page 25 of 524
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968201
Page 26 of 524
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968202
Page 27 of 524
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968203
Page 28 of 524
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968204
Page 29 of 524
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968205
Page 30 of 524
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968206
Page 31 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020 Comments
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968207
Page 32 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Not Done
//Comments
2.Date of First Symptom Started: Not Done
//Comments
3.Symptoms Ongoing? Not Done Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? Not Done Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? Not Done Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? Not Done Comments
4.dSymptoms: CHILLS
Was symptom present? Not Done Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? Not Done Comments
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? Not Done Comments
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? Not Done Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968208
Page 33 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
4.hSymptoms: DIARRHEA
Was symptom present? Not Done Comments
4.iSymptoms: VOMITING
Was symptom present? Not Done Comments
Symptoms - Other
5.Symptoms - Other Text: Not Done
[ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968209
Page 34 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
1. DELETED Sep/27/20
20 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968210
Page 35 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Sep/27/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: CEPHEID XPERT XPRESS SARS-COV-2 TEST
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968211
Page 36 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968212
Page 37 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968213
Page 38 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: Not Done Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: Not Done Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: Not Done Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: Not Done Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: Not Done Comments
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: Not Done Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: Not Done
[ ]Comments
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?Not Done Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968214
Page 39 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968215
Page 40 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968216
Page 41 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Was a diagnosis obtained for
Potential COVID-19 Illness?Not Done Comments
3.Toxicity Grade: Not Done Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968217
Page 42 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968218
Page 43 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968219
Page 44 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined Ide
ntifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968220
Page 45 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968221
Page 46 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968222
Page 47 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968223
Page 48 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968224
Page 49 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest:Result
:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968225
Page 50 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968226
Page 51 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968227
Page 52 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968228
Page 53 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968229
Page 54 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968230
Page 55 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968231
Page 56 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968232
Page 57 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968233
Page 58 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968234
Page 59 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968235
Page 60 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968236
Page 61 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968237
Page 62 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Don
e Repeating
Pages
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968238
Page 63 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968239
Page 64 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968240
Page 65 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968241
Page 66 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968242
Page 67 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968243
Page 68 of 524
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968244
Page 69 of 524
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Unplanned Assessments
1.Assessments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968245
Page 70 of 524
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/23/2020 Comments
2.Phase of Disposition: VACCINATION Comments
3.Status: LOST TO FOLLOW-UP Comments
4.Specify Status: [patient is lost to follow-up, no response on calls or certified letter] Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968246
Page 71 of 524
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Nov/23/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: LOST TO FOLLOW-UP
4.Specify Status: [subject is lost to follow up, 3 calls and certified letter sent]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968247
Page 72 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968248
Page 73 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968249
Page 74 of 524
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
1. ADVERSE E
VENT 1 Left Hip Closed Fract
ure Sep/9/2020 03:0
0 NO
End Date Time:
Sep/25/2020 UNK:U
NK
Repeating
Pages
2. ADVERSE E
VENT 2 Fall Sep/9/2020 03:0
0 NO
End Date Time:
Sep/9/2020 03:00
Repeating
Pages
3. ADVERSE E
VENT 3 Psychosis Sep/27/2020 UN
K:UNK YES Repeating
Pages
4. ADVERSE E
VENT 4 worsening of COPD Aug/26/2020 U
NK:UNK NO
End Date Time:
Aug/27/2020 UNK:U
NK
Repeating
Pages
5. DELETED ADVERSE E
VENT 5 viral illness (unspecifi
ed) Sep/27/2020 UN
K:UNK NO
End Date Time:
Sep/28/2020 UNK:U
NK
Repeating
Pages
6. ADVERSE E
VENT 6 worsening of polysubs
tance abuse Sep/27/2020 UN
K:UNK NO
End Date Time:
Sep/28/2020 UNK:U
NK
Repeating
Pages
7. ADVERSE E
VENT 7 nausea Sep/27/2020 UN
K:UNK NO
End Date Time:
Sep/28/2020 UNK:U
NK
Repeating
Pages
8. DELETED ADVERSE E
VENT 8 vomiting Sep/27/2020 UN
K:UNK NO
End Date Time:
Sep/28/2020 UNK:URepeating
Pages
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968250
Page 75 of 524
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
NK
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968251
Page 76 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Left Hip Closed Fracture]
4.Start Date Time: Sep/9/2020 03:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/25/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Fall]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968252
Page 77 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020373502]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968253
Page 78 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Fall]
4.Start Date Time: Sep/9/2020 03:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/9/2020 03:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[fall from dumpster]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968254
Page 79 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968255
Page 80 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Psychosis]
4.Start Date Time: Sep/27/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Hx of mental disorders]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968256
Page 81 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE Comments
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020386412]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968257
Page 82 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[worsening of COPD]
4.Start Date Time: Aug/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/27/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Med HX of COPD]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968258
Page 83 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968259
Page 84 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[viral illness (unspecified) ]
4.Start Date Time: Sep/27/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/28/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[VIRUS (UNSPECIFIED) ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968260
Page 85 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968261
Page 86 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[worsening of polysubstance abuse]
4.Start Date Time: Sep/27/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/28/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[medical history of polysubstance abuse]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968262
Page 87 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968263
Page 88 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[nausea]
4.Start Date Time: Sep/27/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/28/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[subject detoxing from substance use]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968264
Page 89 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968265
Page 90 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[vomiting]
4.Start Date Time: Sep/27/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/28/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[subject detoxing from substance use ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968266
Page 91 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968267
Page 92 of 524
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968268
Page 93 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968269
Page 94 of 524
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968270
Page 95 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968271
Page 96 of 524
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968272
Page 97 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968273
Page 98 of 524
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968274
Page 99 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968275
Page 100 of 524
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968276
Page 101 of 524
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968277
Page 102 of 524
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968278
Page 103 of 524
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968279
Page 104 of 524
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968280
Page 105 of 524
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968281
Page 106 of 524
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968282
Page 107 of 524
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968283
Page 108 of 524
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968284
Page 109 of 524
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968285
Page 110 of 524
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968286
Page 111 of 524
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968287
Page 112 of 524
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968288
Page 113 of 524
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Not Done
//Comments
2.Primary Reason for Unblinding: Not Done Comments
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968289
Page 114 of 524
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968290
Page 115 of 524
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968291
Page 116 of 524
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/23/2020
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968292
Page 117 of 524
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968293
Page 118 of 524
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Cecil Farrington Approved Mar-09-2021 21:50:12 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, CecilFarrington, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-0968294
Page 119 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormAug-25-2020 16:35:41 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968295
Page 120 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormOct-06-2020 12:36:27 (UTC-05:00) Eastern Time
(US & Canada)
FormAug-25-2020 16:37:40 (UTC-05:00) Eastern Time
(US & Canada)none at screening
Not Applicable
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968296
Page 121 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.aOct-06-2020 12:37:37 (UTC-05:00) Eastern Time
(US & Canada)unknown per source
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968297
Page 122 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.bOct-06-2020 12:40:32 (UTC-05:00) Eastern Time
(US & Canada)Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968298
Page 123 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.cOct-06-2020 12:41:02 (UTC-05:00) Eastern Time
(US & Canada)Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968299
Page 124 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.dOct-06-2020 12:41:42 (UTC-05:00) Eastern Time
(US & Canada)started prior to informed consent
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968300
Page 125 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.eOct-06-2020 12:42:31 (UTC-05:00) Eastern Time
(US & Canada)started prior to ICF signed, date unknown per
source
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968301
Page 126 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.iOct-06-2020 12:44:02 (UTC-05:00) Eastern Time
(US & Canada)started prior to ICF signing
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0968302
Page 127 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.jOct-06-2020 12:45:12 (UTC-05:00) Eastern Time
(US & Canada)ongoing prior to signing ICF
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968303
Page 128 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.kOct-06-2020 12:46:30 (UTC-05:00) Eastern Time
(US & Canada)ongoing prior to signing ICF
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968304
Page 129 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.lOct-06-2020 12:46:59 (UTC-05:00) Eastern Time
(US & Canada)ongoing prior to signing ICF
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968305
Page 130 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.mOct-06-2020 12:49:58 (UTC-05:00) Eastern Time
(US & Canada)ongoing prior to signing ICF
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968306
Page 131 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.nOct-06-2020 12:50:33 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968307
Page 132 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.pOct-06-2020 12:51:25 (UTC-05:00) Eastern Time
(US & Canada)ongoing prior to signing ICF
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968308
Page 133 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.qOct-06-2020 12:52:02 (UTC-05:00) Eastern Time
(US & Canada)ongoing prior to signing ICF
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968309
Page 134 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.qOct-06-2020 14:41:59 (UTC-05:00) Eastern Time
(US & Canada)date is unknown,event occurred prior to signing
ICF
Unknown
1.qOct-06-2020 12:52:21 (UTC-05:00) Eastern Time
(US & Canada)date is unknown, ongoing prior to signing ICF
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968310
Page 135 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.tOct-06-2020 14:45:09 (UTC-05:00) Eastern Time
(US & Canada)unknown start date- ongoing prior to signing ICF
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968311
Page 136 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.tOct-06-2020 14:45:46 (UTC-05:00) Eastern Time
(US & Canada)biopsy stop date is unknown-event occurred prior
to signing ICF
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968312
Page 137 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.uOct-06-2020 14:47:03 (UTC-05:00) Eastern Time
(US & Canada)unknown start date- ongoing prior to signing ICF
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968313
Page 138 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.uOct-06-2020 14:47:30 (UTC-05:00) Eastern Time
(US & Canada)unknown stop date- event occurred prior to signing
ICF
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968314
Page 139 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.vOct-06-2020 14:48:13 (UTC-05:00) Eastern Time
(US & Canada)unknown start date- event occurred prior to signing
ICF
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968315
Page 140 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.vOct-06-2020 14:48:34 (UTC-05:00) Eastern Time
(US & Canada)unknown stop date- event occurred prior to signing
ICF
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968316
Page 141 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.wOct-06-2020 14:49:07 (UTC-05:00) Eastern Time
(US & Canada)unknown start date- event occurred prior to signing
ICF
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968317
Page 142 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.wOct-06-2020 14:49:26 (UTC-05:00) Eastern Time
(US & Canada)unknown stop date- event occurred prior to signing
ICF
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968318
Page 143 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.xOct-07-2020 08:41:01 (UTC-05:00) Eastern Time
(US & Canada)prior to ICF, date is unknown
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968319
Page 144 of 524
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.xOct-07-2020 08:41:36 (UTC-05:00) Eastern Time
(US & Canada)procedure occurred prior to consent
Unknown
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968320
Page 145 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormOct-06-2020 10:43:56 (UTC-05:00) Eastern Time
(US & Canada)subject in hospital, visit not done
Not Done
FormOct-06-2020 10:43:31 (UTC-05:00) Eastern Time
(US & Canada)
FormSep-30-2020 16:16:16 (UTC-05:00) Eastern Time
(US & Canada)visit has not been completed will update once
completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968321
Page 146 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Oct-06-2020 10:43:56 (UTC-05:00) Eastern Time
(US & Canada)subject in hospital, visit not done
Not Done
1Oct-06-2020 10:43:31 (UTC-05:00) Eastern Time
(US & Canada)
1Sep-30-2020 16:16:16 (UTC-05:00) Eastern Time
(US & Canada)visit has not been completed will update once
completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968322
Page 147 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Oct-06-2020 10:43:56 (UTC-05:00) Eastern Time
(US & Canada)subject in hospital, visit not done
Not Done
2Oct-06-2020 10:43:31 (UTC-05:00) Eastern Time
(US & Canada)
2Sep-30-2020 16:16:16 (UTC-05:00) Eastern Time
(US & Canada)visit has not been completed will update once
completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968323
Page 148 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormOct-06-2020 14:40:44 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968324
Page 149 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Oct-06-2020 14:40:44 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968325
Page 150 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.aOct-06-2020 14:40:44 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968326
Page 151 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.aOct-06-2020 14:40:44 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968327
Page 152 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.aOct-06-2020 14:40:44 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968328
Page 153 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormOct-06-2020 14:40:33 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968329
Page 154 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Oct-06-2020 14:40:33 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968330
Page 155 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Oct-06-2020 14:40:33 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968331
Page 156 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Oct-06-2020 14:40:33 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968332
Page 157 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Oct-06-2020 14:40:33 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968333
Page 158 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormOct-06-2020 14:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968334
Page 159 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Oct-06-2020 14:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968335
Page 160 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Oct-06-2020 14:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968336
Page 161 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Oct-06-2020 14:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968337
Page 162 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Oct-06-2020 14:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968338
Page 163 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Oct-06-2020 14:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968339
Page 164 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Oct-06-2020 14:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968340
Page 165 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
7Oct-06-2020 14:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968341
Page 166 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
8Oct-06-2020 14:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968342
Page 167 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
9Oct-06-2020 14:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968343
Page 168 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
10Oct-06-2020 14:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968344
Page 169 of 524
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
11Oct-06-2020 14:40:55 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968345
Page 170 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: DATE OF VISIT - ILLNESS ONSET - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Oct-15-2020 15:49:28 (UTC-05:00) Eastern Time
(US & Canada)visit was not completed in person. subject is
hospitialized and all information was recorded
from medical records. subject has polysubstance
abuse and was detoxing. added covid illness visit as
per query since subject had nausea and vomiting
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968346
Page 171 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormOct-20-2020 15:26:12 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968347
Page 172 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Oct-20-2020 15:26:12 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968348
Page 173 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Oct-20-2020 15:26:12 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968349
Page 174 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Oct-20-2020 15:26:12 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968350
Page 175 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4.aOct-20-2020 15:26:12 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968351
Page 176 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4.bOct-20-2020 15:26:12 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968352
Page 177 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4.cOct-20-2020 15:26:12 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968353
Page 178 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4.dOct-20-2020 15:26:12 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968354
Page 179 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4.eOct-20-2020 15:26:12 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968355
Page 180 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4.fOct-20-2020 15:26:12 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968356
Page 181 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4.gOct-20-2020 15:26:12 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968357
Page 182 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4.hOct-20-2020 15:26:12 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968358
Page 183 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4.iOct-20-2020 15:26:12 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968359
Page 184 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormMar-04-2021 16:19:22 (UTC-05:00) Eastern Time
(US & Canada)not applicable
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968360
Page 185 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormOct-20-2020 15:27:15 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
FormOct-13-2020 10:24:32 (UTC-05:00) Eastern Time
(US & Canada)
FormOct-09-2020 08:30:06 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0968361
Page 186 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Oct-20-2020 15:27:15 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
1Oct-13-2020 10:24:32 (UTC-05:00) Eastern Time
(US & Canada)
1Oct-09-2020 08:30:06 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968362
Page 187 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Oct-20-2020 15:27:15 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
2Oct-13-2020 10:24:32 (UTC-05:00) Eastern Time
(US & Canada)
2Oct-09-2020 08:30:06 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968363
Page 188 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Oct-20-2020 15:27:15 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
3Oct-13-2020 10:24:32 (UTC-05:00) Eastern Time
(US & Canada)
3Oct-09-2020 08:30:06 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968364
Page 189 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Oct-20-2020 15:27:15 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
4Oct-13-2020 10:24:32 (UTC-05:00) Eastern Time
(US & Canada)
4Oct-09-2020 08:30:06 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968365
Page 190 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormOct-20-2020 15:27:55 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
FormOct-13-2020 10:25:11 (UTC-05:00) Eastern Time
(US & Canada)
FormOct-09-2020 08:30:18 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968366
Page 191 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Oct-20-2020 15:27:55 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
1Oct-13-2020 10:25:11 (UTC-05:00) Eastern Time
(US & Canada)
1Oct-09-2020 08:30:18 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968367
Page 192 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Oct-20-2020 15:27:55 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
2Oct-13-2020 10:25:11 (UTC-05:00) Eastern Time
(US & Canada)
2Oct-09-2020 08:30:18 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968368
Page 193 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Oct-20-2020 15:27:55 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
3Oct-13-2020 10:25:11 (UTC-05:00) Eastern Time
(US & Canada)
3Oct-09-2020 08:30:18 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968369
Page 194 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Oct-20-2020 15:27:55 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
4Oct-13-2020 10:25:11 (UTC-05:00) Eastern Time
(US & Canada)
4Oct-09-2020 08:30:18 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0968370
Page 195 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormOct-20-2020 15:32:21 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968371
Page 196 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.aOct-20-2020 15:32:21 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968372
Page 197 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.bOct-20-2020 15:32:21 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968373
Page 198 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.cOct-20-2020 15:32:21 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968374
Page 199 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.dOct-20-2020 15:32:21 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968375
Page 200 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.eOct-20-2020 15:32:21 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968376
Page 201 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.fOct-20-2020 15:32:21 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968377
Page 202 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Oct-20-2020 15:32:21 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968378
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Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Oct-20-2020 15:32:21 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968379
Page 204 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormOct-09-2020 08:31:14 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968380
Page 205 of 524
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Oct-09-2020 08:31:14 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968381
Page 206 of 524
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Oct-09-2020 08:31:14 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968382
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Oct-09-2020 08:31:14 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968383
Page 208 of 524
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Oct-09-2020 08:31:14 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968384
Page 209 of 524
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Oct-09-2020 08:31:14 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968385
Page 210 of 524
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Oct-09-2020 08:31:14 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968386
Page 211 of 524
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormOct-20-2020 15:35:05 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
FormOct-12-2020 13:54:51 (UTC-05:00) Eastern Time
(US & Canada)
FormOct-09-2020 08:31:33 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0968387
Page 212 of 524
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Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Oct-20-2020 15:35:05 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
1Oct-12-2020 13:54:51 (UTC-05:00) Eastern Time
(US & Canada)
1Oct-09-2020 08:31:33 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0968388
Page 213 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Oct-20-2020 15:35:05 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
2Oct-12-2020 13:54:51 (UTC-05:00) Eastern Time
(US & Canada)
2Oct-09-2020 08:31:33 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0968389
Page 214 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Oct-20-2020 15:35:05 (UTC-05:00) Eastern Time
(US & Canada)entered in error. visit not completed
Not Done
3Oct-12-2020 13:54:51 (UTC-05:00) Eastern Time
(US & Canada)
3Oct-09-2020 08:31:33 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968390
Page 215 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormOct-09-2020 08:32:17 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968391
Page 216 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Oct-09-2020 08:32:17 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968392
Page 217 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Oct-09-2020 08:32:17 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968393
Page 218 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Oct-09-2020 08:32:17 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968394
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Oct-09-2020 08:32:17 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968395
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968396
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Oct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968397
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Oct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968398
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Oct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968399
Page 224 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Oct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968400
Page 225 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968401
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968402
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968403
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968404
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968405
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968406
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968407
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968408
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968409
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968410
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968411
Page 236 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968412
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968413
Page 238 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968414
Page 239 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968415
Page 240 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968416
Page 241 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968417
Page 242 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968418
Page 243 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968419
Page 244 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968420
Page 245 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.fOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968421
Page 246 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.fOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968422
Page 247 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.fOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968423
Page 248 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.fOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968424
Page 249 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968425
Page 250 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968426
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968427
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gOct-09-2020 08:34:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968428
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968429
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Oct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968430
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Oct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968431
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Oct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968432
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Oct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968433
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968434
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968435
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968436
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968437
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968438
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968439
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968440
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
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Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968442
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968443
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968444
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968445
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968446
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968447
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968448
Page 273 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968449
Page 274 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968450
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968451
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968452
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968453
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.fOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968454
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.fOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968455
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.fOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968456
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.fOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968457
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968458
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968459
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968460
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968461
Page 286 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.hOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968462
Page 287 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.hOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968463
Page 288 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.hOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968464
Page 289 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.hOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968465
Page 290 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.iOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0968466
Page 291 of 524
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/05/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1089 Site Name: (1089) PMG Research of Salisbury
Subject No: 10891182 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.iOct-09-2020 08:34:32 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f2c\Final\Final On: 01-Apr-2021 03:37 (GMT)
(b) (4), (b) (6)
(b) (4
…[truncated]