Document text
Page 1 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934913
Page 2 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/27/2020
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934914
Page 3 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11311095]
2.Birth Date: /1960
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0934915
Page 4 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020 Comments
2.Erroneous Visit
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934916
Page 5 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934917
Page 6 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/9/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934918
Page 7 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[dizziness, related to travel by boat]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[myopia]
Start Date: UNK/UNK/1966
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[eye glass wearer]
Start Date: UNK/UNK/1966
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[contact wearer]
Start Date: UNK/UNK/1966
Ongoing: YES
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934919
Page 8 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cataracts in both eyes, mild]
Start Date: May/UNK/2020
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergic rhinitis, seasonal]
Start Date: UNK/UNK/1972
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[elevated cholesterol, specific level unknown]
Start Date: UNK/UNK/2015
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gallstones]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[migraine headaches]
Start Date: UNK/UNK/1979
Ongoing: YES
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934920
Page 9 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypothyroidism]
Start Date: UNK/UNK/1989
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[lower back pain, undiagnosed etiology]
Start Date: UNK/UNK/2018
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteopenia]
Start Date: UNK/UNK/2019
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[vitamin D deficiency]
Start Date: Apr/UNK/2020
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hashimoto disease]
Start Date: UNK/UNK/1989
Ongoing: YES
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934921
Page 10 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hysterectomy]
Start Date: UNK/UNK/2003
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cholecystectomy]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934922
Page 11 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
2.Weight: [73.6]
3.Unit: kg
4.Height: [168.5]
5.Unit: cm
6.Body Mass Index: [25.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934923
Page 12 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934924
Page 13 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/9/2020
2.Randomization Number: [255945]
3.Randomization Group: [ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934925
Page 14 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BL9W13]
5.bSample ID [BL9W14]
5.cSample ID [BP99P2]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934926
Page 15 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BN6DZX]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934927
Page 16 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Aug/27/2020
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNESS
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/9/2020 14:33
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
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934928
Page 17 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934929
Page 18 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/29/2020
2.Erroneous Visit
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934930
Page 19 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934931
Page 20 of 416
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934932
Page 21 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
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 [BP9B2R]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934933
Page 22 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: Sep/29/2020 15:10
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
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934934
Page 23 of 416
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/28/2020
2.Erroneous Visit
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934935
Page 24 of 416
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/28/2020
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 [BS7X8P]
5.bSample ID [BS7X8M]
5.cSample ID [BP99Y9]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934936
Page 25 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934937
Page 26 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/15/2020
2.Date of First Symptom Started: Dec/14/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/12/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934938
Page 27 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [laryngitis]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934939
Page 28 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934940
Page 29 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934941
Page 30 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Dec/16/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[patient to bring swab into office]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV00808]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934942
Page 31 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[patient was instructed to self swab and bring to the site]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934943
Page 32 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934944
Page 33 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934945
Page 34 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934946
Page 35 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934947
Page 36 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable
Repeating Pages
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934948
Page 37 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934949
Page 38 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable
Not Appli
cable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934950
Page 39 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934951
Page 40 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934952
Page 41 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934953
Page 42 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934954
Page 43 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.Not Applicabl
e Not Applicable Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934955
Page 44 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934956
Page 45 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934957
Page 46 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934958
Page 47 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934959
Page 48 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934960
Page 49 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934961
Page 50 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934962
Page 51 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934963
Page 52 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934964
Page 53 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934965
Page 54 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934966
Page 55 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934967
Page 56 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934968
Page 57 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable 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 Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934969
Page 58 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934970
Page 59 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934971
Page 60 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/12/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934972
Page 61 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/12/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/12/2021
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 [BS7XRF]
5.bSample ID [BS7XRD]
5.cSample ID [BR0F7D]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934973
Page 62 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934974
Page 63 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934975
Page 64 of 416
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934976
Page 65 of 416
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934977
Page 66 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934978
Page 67 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934979
Page 68 of 416
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 malaise Sep/30/2020 UNK
:UNK NO
End Date Time:
Oct/1/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 swollen axillary lymp
h nodes Sep/30/2020 UNK
:UNK NO
End Date Time:
Oct/2/2020 UNK:UNK
Repeating
Pages
3.ADVERSE EV
ENT 3 headache Sep/30/2020 07:0
0 NO
End Date Time:
Oct/2/2020 UNK:UNK
Repeating
Pages
4.ADVERSE EV
ENT 4 generalized myalgia Oct/2/2020 02:00 NO
End Date Time:
Oct/2/2020 08:00
Repeating
Pages
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934980
Page 69 of 416
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[malaise]
4.Start Date Time: Sep/30/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/1/2020 UNK:UNK
6.Toxicity Grade: 1
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934981
Page 70 of 416
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934982
Page 71 of 416
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[swollen axillary lymph nodes]
4.Start Date Time: Sep/30/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/2/2020 UNK:UNK
6.Toxicity Grade: 1
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934983
Page 72 of 416
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934984
Page 73 of 416
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[headache]
4.Start Date Time: Sep/30/2020 07:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/2/2020 UNK:UNK
6.Toxicity Grade: 1
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934985
Page 74 of 416
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934986
Page 75 of 416
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[generalized myalgia]
4.Start Date Time: Oct/2/2020 02:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/2/2020 08:00
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:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934987
Page 76 of 416
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934988
Page 77 of 416
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934989
Page 78 of 416
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934990
Page 79 of 416
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934991
Page 80 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: //
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934992
Page 81 of 416
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934993
Page 82 of 416
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934994
Page 83 of 416
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934995
Page 84 of 416
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934996
Page 85 of 416
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934997
Page 86 of 416
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934998
Page 87 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0934999
Page 88 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935000
Page 89 of 416
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935001
Page 90 of 416
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935002
Page 91 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935003
Page 92 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935004
Page 93 of 416
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/22/2020
2.Erroneous Visit
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935005
Page 94 of 416
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935006
Page 95 of 416
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/23/2020
2.Erroneous Visit
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935007
Page 96 of 416
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/23/2020
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935008
Page 97 of 416
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935009
Page 98 of 416
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Dec/23/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935010
Page 99 of 416
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [ ]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done:
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935011
Page 100 of 416
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/23/2020
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 [BR0F57]
5.bSample ID [BS7XN0]
5.cSample ID [BS7XN1]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935012
Page 101 of 416
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/23/2020
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 [BP9B86]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935013
Page 102 of 416
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Dec/23/2020 08:57
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935014
Page 103 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/22/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935015
Page 104 of 416
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935016
Page 105 of 416
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935017
Page 106 of 416
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935018
Page 107 of 416
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935019
Page 108 of 416
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/12/2021
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 [BP9B9F]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935020
Page 109 of 416
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/12/2021 11:29
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935021
Page 110 of 416
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935022
Page 111 of 416
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/9/2021
3.Comments: [ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935023
Page 112 of 416
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935024
Page 113 of 416
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935025
Page 114 of 416
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935026
Page 115 of 416
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935027
Page 116 of 416
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/9/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935028
Page 117 of 416
***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: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/28/2020
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0935029
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Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
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1.Casebook Signature Click Here to Enable
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(b) (4)
FDA-CBER-2021-5683-0935030
Page 119 of 416
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
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(b) (4)
FDA-CBER-2021-5683-0935031
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Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Oct-19-2020 11:02:23 (UTC-05:00) Eastern
Time (US & Canada)
1Aug-31-2020 12:35:19 (UTC-05:00) Eastern
Time (US & Canada)Delayed vaccine per physician due to muscle
pain in neck for several days. No vaccine
administered on the initial screening day so not
considered the "visit date" per CRF guidelines.
Not Done
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935032
Page 121 of 416
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Header Text: c4591001
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormSep-09-2020 19:12:53 (UTC-05:00) Eastern
Time (US & Canada)no inclusion or exclusion criteria met
Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935033
Page 122 of 416
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Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Sep-10-2020 08:54:13 (UTC-05:00) Eastern
Time (US & Canada)subject not of childbearing age
Not Done
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Sep-29-2020 15:45:32 (UTC-05:00) Eastern
Time (US & Canada)subject not of childbearing potential
Not Done
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935035
Page 124 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-16-2020 08:37:07 (UTC-05:00) Eastern
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090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935036
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-16-2020 08:37:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935037
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-16-2020 08:37:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935038
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Dec-16-2020 08:37:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935039
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Dec-16-2020 08:37:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935040
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Dec-16-2020 08:37:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935041
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6Dec-16-2020 08:37:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935042
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
7Dec-16-2020 08:37:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935043
Page 132 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
8Dec-16-2020 08:37:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935044
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
9Dec-16-2020 08:37:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935045
Page 134 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: RESPIRATORY TREATMENT - Comments
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-16-2020 08:31:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
FormDec-16-2020 08:31:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935046
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-16-2020 08:31:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
1Dec-16-2020 08:31:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935047
Page 136 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-16-2020 08:31:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
2Dec-16-2020 08:31:27 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4), (b) (6)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935048
Page 137 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Dec-16-2020 08:31:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Time (US & Canada)Not Done
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(b) (4), (b) (6)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935049
Page 138 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: RESPIRATORY TREATMENT - Comments
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Dec-16-2020 08:31:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0935050
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Dec-16-2020 08:31:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0935051
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: RESPIRATORY TREATMENT - Comments
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0935052
Page 141 of 416
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-16-2020 08:32:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0935053
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0935054
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-16-2020 08:32:27 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0935055
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0935056
Page 145 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0935057
Page 146 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-16-2020 08:32:45 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935058
Page 147 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-16-2020 08:32:45 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935059
Page 148 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-16-2020 08:32:45 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935060
Page 149 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Dec-16-2020 08:32:45 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935061
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FDA-CBER-2021-5683-0935062
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935063
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935064
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0935065
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
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FDA-CBER-2021-5683-0935066
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935067
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
5.bDec-16-2020 08:32:45 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935068
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935069
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
5.bDec-16-2020 08:32:45 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935070
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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ItemDate User Comment
5.cDec-16-2020 08:32:45 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0935071
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935072
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935073
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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ItemDate User Comment
5.cDec-16-2020 08:32:45 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935074
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935075
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935076
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935077
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935078
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0935079
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0935080
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0935081
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0935082
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935083
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
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FDA-CBER-2021-5683-0935084
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
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FDA-CBER-2021-5683-0935085
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
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090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
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FDA-CBER-2021-5683-0935086
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
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090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
5.gDec-16-2020 08:32:45 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
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FDA-CBER-2021-5683-0935088
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-16-2020 08:32:45 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935089
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-16-2020 08:32:45 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935090
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935091
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Dec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935092
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Dec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935093
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
3Dec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
4Dec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935095
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935096
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935097
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935098
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.aDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935099
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935100
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935101
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935102
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.bDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935103
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.cDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935104
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.cDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935105
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.cDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935106
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.cDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935107
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.dDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935108
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.dDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935109
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.dDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935110
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.dDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935111
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935112
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935113
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935114
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.eDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935115
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 fDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935116
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 fDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935117
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 fDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935118
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 fDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935119
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935120
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935121
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935122
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5.gDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935123
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 hDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935124
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 hDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935125
Page 214 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5 hDec-16-2020 08:33:02 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935126
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935127
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935128
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935129
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935130
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935131
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935132
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935133
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935134
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935135
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
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FormDec-16-2020 08:33:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935136
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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1Dec-16-2020 08:33:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935137
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935138
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935139
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935140
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935141
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935142
Page 231 of 416
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
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Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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1Dec-16-2020 08:33:56 (UTC-05:00) Eastern
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935143
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935144
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 11311095 Subject Initials: ---
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Back to Form
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FormDec-16-2020 08:34:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935145
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
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1Dec-16-2020 08:34:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935146
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
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Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0935147
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
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Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0935148
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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FormDec-16-2020 08:34:45 (UTC-05:00) Eastern
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FDA-CBER-2021-5683-0935149
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0935150
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
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FDA-CBER-2021-5683-0935151
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
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FDA-CBER-2021-5683-0935154
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
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FDA-CBER-2021-5683-0935155
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-16-2020 08:34:58 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0935156
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
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Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0935157
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
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FDA-CBER-2021-5683-0935158
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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ItemDate User Comment
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Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0935159
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***Confidential***
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on Dec/15/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Dec-16-2020 08:34:58 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935160
Page 249 of 416
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormDec-30-2020 09:05:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935161
Page 250 of 416
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Dec-30-2020 09:31:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935162
Page 251 of 416
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Jan-12-2021 14:34:39 (UTC-05:00) Eastern
Time (US & Canada)patient is 60 years old
Not Applicable
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935163
Page 252 of 416
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-09-2021 13:06:46 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Randall Approved Jan-22-2021 12:31:35 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamRandall, 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.
N/A Nov-24-2020 13:12:24 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
William
Randall Approved Nov-03-2020 09:07:27 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, WilliamRandall, 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.
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935164
Page 253 of 416
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-31-2020 12:23:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-31-2020 12:23:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935165
Page 254 of 416
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-23-2020 00:21:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-22-2020 09:05:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Oct-22-2020 07:36:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Vaccination CRF
is unfrozen, please
consider updating as
appropriate. Thank
you.
Oct-20-2020 09:37:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Vaccination CRF Data
is frozen; if unfrozen,
the EDC will be
updated.
Oct-20-2020 08:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: As per
VACCINATION CRF
at
V1_DAY1_VAX1_L,
there is no temporary
delay of vaccination
recorded. Please
consider to update
VACCINATION CRF
if appropriate. Thanks
Oct-19-2020 11:10:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Correct as is-
informed consent
obtained on
27AUG2020 and due
to delay of vaccine
because of muscle
pain in neck, visit 1
finished on
09SEP2020.
Oct-19-2020 11:04:05
(UTC-05:00) EasternACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date Informed
Consent Obtained is
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935166
Page 255 of 416
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada) not the same as the
Date of Visit. Please
correct as necessary.
Aug-31-2020 12:23:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Aug/27/2020Initial Entry
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935167
Page 256 of 416
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-31-2020 12:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11311095Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-31-2020 12:23:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1960Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-31-2020 12:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-31-2020 12:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-31-2020 12:24:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935168
Page 257 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-23-2020 00:20:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-22-2020 09:05:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Oct-22-2020 07:37:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: Vaccination CRF
is unfrozen, please
consider updating as
appropriate. Thank
you.
Oct-20-2020 09:36:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Vaccination CRF Data
is frozen; if unfrozen,
the EDC will be
updated.
Oct-20-2020 08:13:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM: As per
VACCINATION CRF
at
V1_DAY1_VAX1_L,
there is no temporary
delay of vaccination
recorded. Please
consider to update
VACCINATION CRF
if appropriate. Thanks
Oct-19-2020 11:04:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Delayed vaccine per
physician due to
muscle pain in neck
for several days. No
vaccine administered
on the initial
screening day so not
considered the "visit
date" per CRF
guidelines. Vaccine
administered on 9SEP
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935169
Page 258 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
so EDC is updated.
Oct-19-2020 11:04:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Delayed vaccine per
physician due to
muscle pain in neck
for several days. No
vaccine administered
on the initial
screening day so not
considered the "visit
date" per CRF
guidelines. Vaccine
administered on 9SEP
so EDC is updated.
Oct-19-2020 11:02:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Oct-18-2020 02:17:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 1: Opened Subject received
vaccination on
09Sep2020, but Date
of visit is marked as
NOT DONE. Please
verify and update the
date. Else clarify.
Aug-31-2020 12:35:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0935170
Page 259 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-10-2020 16:26:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/9/2020Delay of vaccine
administration and
the screening visit
was completed
9SEP2020.
Aug-31-2020 12:29:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-31-2020 12:29:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-11-2020 02:44:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Per site
confirmation
Sep-10-2020 08:36:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Closed Close Auto Query
Sep-10-2020 08:35:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Opened Response to
"Status" is
COMPLETED but
"Specify Status" is
Provided.
Sep-10-2020 08:35:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered New Information
Sep-10-2020 08:35:49
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
COMPLETEDNew Information
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935171
Page 260 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
Sep-10-2020 01:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Reissued:Opened DM: The page is
unfreeze. Per
response please
consider to update
the data as
appropriate.
Sep-09-2020 19:14:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered page is frozen.page
needs to be unfrozen
for me to be able to
update the subjects
status and enter visit
info, including
barcodes
Sep-09-2020 02:37:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Reissued:Opened DM2: Thank you
for confirming.
Please respond to
query only once
updates are made.
Sep-08-2020 10:06:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Still waiting on
CRA Dominic
Mainello's guidance
for delay vaccine
EDC. Will query
again- Thank you
for your patience.
Sep-07-2020 08:02:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Reissued:Opened DM Requery:
Thanks for your
response. Once
guidance receive
from the CRA,
Kindly update the
screening
disposition status.
Sep-03-2020 09:13:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Thank you for your
patience, this
subject had a delay
in vaccine
administration and
didn't get
randomized or
complete Visit 1.
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935172
Page 261 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
We are seeking
guidance from CRA
how to best
categorize the
screening
disposition. It wasn't
completed or a
screen failure.
Sep-03-2020 08:44:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened SDQ: As per
Impala, Subject
status is Screening.
Please review and
update as
appropriate. Thank
you.
Aug-31-2020 12:31:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Aug-31-2020 12:31:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Response to
"Status" is OTHER
but "Specify Status"
is missing.
Aug-31-2020 12:31:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-31-2020 12:31:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERChanged
Information
Aug-31-2020 12:29:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to
"Status" is
PHYSICIAN
DECISION but
"Specify Status" is
Provided.
Aug-31-2020 12:29:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PHYSICIAN DECISIONInitial Entry
4. Specify Status:
Date Location User Value Reason
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0935173
Page 262 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-10-2020 08:36:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: New Information
Aug-31-2020 12:31:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Delayed vaccine per physician d
ue to muscle pain in neck for se
veral days.Initial Entry
Aug-31-2020 12:31:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Aug-31-2020 12:29:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Delayed vaccine per physician d
ue to muscle pain in neck for se
veral days.Initial Entry
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935174
Page 263 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Sep-10-2020 08:38:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:dizziness, related t
o travel by boat
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-10-2020 08:38:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 08:38:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
dizziness, related to travel by boa
tInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-10-2020 08:38:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-10-2020 08:38:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
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FDA-CBER-2021-5683-0935175
Page 264 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.b
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Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
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:2
Medical History T
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Start Date: UNK/UNK/1
966
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-10-2020 08:38:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
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1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 08:38:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
myopiaInitial Entry
1.b Start Date:
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Sep-10-2020 08:38:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1966Initial Entry
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Time (US & Canada)ACV0PFEINFP6000 Data Entry:
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1.c
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(b)
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(b)
(4),
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(b)
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FDA-CBER-2021-5683-0935176
Page 265 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Sep-10-2020 08:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:eye glass wea
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Start Date: UNK/UNK/1
966
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-10-2020 08:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 08:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
eye glass wearerInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-10-2020 08:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1966Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-10-2020 08:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935177
Page 266 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-10-2020 08:39:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:contact weare
r
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966
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Sep-10-2020 08:39:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 08:39:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
contact wearerInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-10-2020 08:39:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1966Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-10-2020 08:39:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-10-2020 08:39:27
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num 5Initial Entry
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935178
Page 267 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada) ber:
Medical Histor
y Term:cataracts in both
eyes, mild
Start Date: May/UNK/2020
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Sep-10-2020 08:39:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 08:39:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cataracts in both eyes, mildInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-10-2020 08:39:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
May/UNK/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-10-2020 08:39:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-10-2020 08:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:allergic rhinitis,
seasonalInitial Entry
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935179
Page 268 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Start Date: UNK/UNK/197
2
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Sep-10-2020 08:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 08:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
allergic rhinitis, seasonalInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-10-2020 08:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1972Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-10-2020 08:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
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Sep-10-2020 08:40:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:7
Medical Hi
story Term
:elevated cholesterol,
specific level unkno
wn
Start Date: UNK/UNK/2015Initial Entry
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b)
(4),
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(b)
(4),
(b) (6)
(b)
(4),
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(b) (4)
FDA-CBER-2021-5683-0935180
Page 269 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Sep-10-2020 08:40:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 08:40:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
elevated cholesterol, specific lev
el unknownInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-10-2020 08:40:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-10-2020 08:40:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-10-2020 08:40:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:8
Medical History
Term:gallstones
Start Date: UNK/UNK/200
6Initial Entry
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b)
(4),
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(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935181
Page 270 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: NO
End Date:
UNK/UNK/
2006
1.h Line/MH Number:
Date Location User Value Reason
Sep-10-2020 08:40:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
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Date Location User Value Reason
Sep-10-2020 08:40:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
gallstonesInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-10-2020 08:40:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2006Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-10-2020 08:40:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2006Initial Entry
1.i
Date Location User Value Reason
Sep-10-2020 08:41:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9Initial Entry
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b)
(4),
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(b)
(4),
(b) (6)
(b)
(4),
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(b) (4)
FDA-CBER-2021-5683-0935182
Page 271 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Medical History
Term:migraine head
aches
Start Date: UNK/UNK/19
79
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Sep-10-2020 08:41:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
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Date Location User Value Reason
Sep-10-2020 08:41:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
migraine headachesInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-10-2020 08:41:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1979Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-10-2020 08:41:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Sep-10-2020 08:42:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:10
Medical History T
erm:hypothyroidis
mInitial Entry
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935183
Page 272 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Start Date: UNK/UNK/1
989
Ongoing: YES
1.j Line/MH Number:
Date Location User Value Reason
Sep-10-2020 08:42:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
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Date Location User Value Reason
Sep-10-2020 08:42:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hypothyroidismInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-10-2020 08:42:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1989Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-10-2020 08:42:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0935184
Page 273 of 416
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1131 Site Name: (1131) PriMED Clinical Research
Subject No: 11311095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.k
Date Location User Value Reason
Sep-10-2020 08:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:11
Medical His
tory Term:lower back pain, un
diagnosed etiology
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Sep-10-2020 08:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 08:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
lower back pain, undiagnosed eti
ologyInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-10-2020 08:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-10-2020 08:42:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
090177e196ae3eac\Final\Final On: 01-Apr-2021 04:58 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA
…[truncated]