Document text
Page 1 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953411
Page 2 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/27/2020
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953412
Page 3 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10771137]
2.Birth Date: /1965
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:
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953413
Page 4 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953414
Page 5 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953415
Page 6 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953416
Page 7 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[INSOMNIA]
Start Date: UNK/UNK/2016
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DEPRESSION]
Start Date: UNK/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PENICILLIN ALLERGY]
Start Date: UNK/UNK/1985
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HEMATOMA LEFT THIGH]
Start Date: Apr/6/2020
Ongoing: YES
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953417
Page 8 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ROSACEA]
Start Date: UNK/UNK/2019
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[POSTMENOPAUSAL]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953418
Page 9 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
2.Weight: [57.8]
3.Unit: kg
4.Height: [157.5]
5.Unit: cm
6.Body Mass Index: [23.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953419
Page 10 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/27/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953420
Page 11 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/27/2020
2.Randomization Number: [69585]
3.Randomization Group: [ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953421
Page 12 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
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 [BP8J33]
5.bSample ID [BP8J34]
5.cSample ID [BP8J35]
5.dSample ID [BPRMR8]
5.eSample ID [BPRMR9]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953422
Page 13 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
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 [BP8J2J]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953423
Page 14 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/27/2020 11:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
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
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953424
Page 15 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953425
Page 16 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953426
Page 17 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953427
Page 18 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/17/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953428
Page 19 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/17/2020
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 [BP1HD2]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953429
Page 20 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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/17/2020 09:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
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
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953430
Page 21 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953431
Page 22 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
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 [BR8JBS]
5.bSample ID [BR8JBT]
5.cSample ID [BR8JBV]
5.dSample ID [BSJLC9]
5.eSample ID [BSJLCB]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953432
Page 23 of 178
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/12/2021
2.Erroneous Visit
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953433
Page 24 of 178
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/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 [BR9RT7]
5.bSample ID [BS0875]
5.cSample ID [BS0876]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953434
Page 25 of 178
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953435
Page 26 of 178
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953436
Page 27 of 178
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953437
Page 28 of 178
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953438
Page 29 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/4/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953439
Page 30 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/4/2020
2.Date of First Symptom Started: Oct/31/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/9/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
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? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953440
Page 31 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Symptoms - Other
5.aSymptoms - Other Text: [HEADACHE]
5.bSymptoms - Other Text: [FATIGUE]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953441
Page 32 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Type Form Instance
1.Not Applicable Not Applicab
le Not Applicable Not Applicable Not Applicab
le Repeating
Pages
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953442
Page 33 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953443
Page 34 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Nov/5/2020
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 [CV02433]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953444
Page 35 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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:[SELF SWAB DONE]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953445
Page 36 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: YES
Number of Visits or Contacts:
[1]
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
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953446
Page 37 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953447
Page 38 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953448
Page 39 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: 2
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953449
Page 40 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953450
Page 41 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953451
Page 42 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
1. Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953452
Page 43 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953453
Page 44 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953454
Page 45 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953455
Page 46 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953456
Page 47 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953457
Page 48 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953458
Page 49 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953459
Page 50 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953460
Page 51 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953461
Page 52 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953462
Page 53 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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.Start Date: //
6.Ongoing?
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953463
Page 54 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953464
Page 55 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953465
Page 56 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/02/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/2/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953466
Page 57 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/02/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/2/2020
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 [BR9D6C]
5.bSample ID [BR9D6D]
5.cSample ID [BR9D6F]
5.dSample ID [BS671X]
5.eSample ID [BS671Y]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953467
Page 58 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953468
Page 59 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953469
Page 60 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Oct/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953470
Page 61 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953471
Page 62 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953472
Page 63 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953473
Page 64 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
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).
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with Study
Treatment:
11.Was a Concomitant Medication
given?
12.Was a Non-Drug Treatment given?
13.What was the outcome of this
adverse event?:
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953474
Page 65 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
14.Did the adverse event cause the
subject to be discontinued from the
study?
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953475
Page 66 of 178
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953476
Page 67 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953477
Page 68 of 178
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953478
Page 69 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: //
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953479
Page 70 of 178
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953480
Page 71 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953481
Page 72 of 178
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953482
Page 73 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953483
Page 74 of 178
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953484
Page 75 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953485
Page 76 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953486
Page 77 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953487
Page 78 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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:
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953488
Page 79 of 178
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953489
Page 80 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953490
Page 81 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953491
Page 82 of 178
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953492
Page 83 of 178
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953493
Page 84 of 178
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953494
Page 85 of 178
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953495
Page 86 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953496
Page 87 of 178
***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
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953497
Page 88 of 178
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/22/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953498
Page 89 of 178
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953499
Page 90 of 178
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953500
Page 91 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/15/2020
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953501
Page 92 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953502
Page 93 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953503
Page 94 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormAug-27-2020 12:30:05 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953504
Page 95 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormNov-05-2020 16:37:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953505
Page 96 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Nov-05-2020 16:37:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953506
Page 97 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Nov-05-2020 16:37:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953507
Page 98 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Nov-05-2020 16:37:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953508
Page 99 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Nov-05-2020 16:37:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953509
Page 100 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Nov-05-2020 16:37:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953510
Page 101 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6Nov-05-2020 16:37:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953511
Page 102 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
7Nov-05-2020 16:37:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953512
Page 103 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
8Nov-05-2020 16:37:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953513
Page 104 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
9Nov-05-2020 16:37:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953514
Page 105 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 Mar-12-2021 16:23:12 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Suchet Patel Approved Mar-12-2021 16:13:18 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SuchetPatel, 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 Feb-19-2021 09:33:35 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Suchet Patel Approved Dec-03-2020 08:18:16 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SuchetPatel, 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.
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953515
Page 106 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
N/A Dec-02-2020 09:42:39 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Suchet Patel Approved Nov-06-2020 17:08:54 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SuchetPatel, 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-05-2020 16:35:54 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Suchet Patel Approved Oct-23-2020 09:34:21 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SuchetPatel, 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.
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953516
Page 107 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-27-2020 12:28:50
(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-27-2020 12:28:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953517
Page 108 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-27-2020 12:29:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/27/2020Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953518
Page 109 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-27-2020 12:28:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10771137Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-27-2020 12:28:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1965Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-27-2020 12:29:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-27-2020 12:29:32
(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-27-2020 12:29:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953519
Page 110 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020 12:29:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953520
Page 111 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-27-2020 12:30:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-27-2020 12:30:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-27-2020 12:30:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953521
Page 112 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Aug-27-2020 12:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:INSOMNIA
Start Date: UNK/UNK/2
016
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-27-2020 12:31:13
(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
Aug-27-2020 12:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
INSOMNIAInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-27-2020 12:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-27-2020 12:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953522
Page 113 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Aug-27-2020 12:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History T
erm:DEPRESSIO
N
Start Date: UNK/UNK/2
018
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-27-2020 12:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 12:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DEPRESSIONInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-27-2020 12:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-27-2020 12:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-27-2020 12:31:49
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num 3Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953523
Page 114 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada) ber:
Medical Histor
y Term:PENICILLIN AL
LERGY
Start Date: UNK/UNK/1985
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-27-2020 12:31:49
(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
Aug-27-2020 12:31:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PENICILLIN ALLERGYInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-27-2020 12:31:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-27-2020 12:31:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-28-2020 11:23:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4
Medical Histo
ry Term:HEMATOMA LE
FT THIGHInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953524
Page 115 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Start Date: Apr/6/2020
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Aug-28-2020 11:23:18
(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
Aug-28-2020 11:23:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEMATOMA LEFT THIGHInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-28-2020 11:23:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/6/2020Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-28-2020 11:23:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-16-2020 15:18:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History T
erm:ROSACEA
Start Date: UNK/UNK/2
019
Ongoing: YESInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953525
Page 116 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.e Line/MH Number:
Date Location User Value Reason
Oct-16-2020 15:18:56
(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
Oct-16-2020 15:18:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ROSACEAInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-16-2020 15:18:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-16-2020 15:18:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-16-2020 15:19:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical History
Term:POSTMENOPA
USAL
Start Date: UNK/UNK/201
6
Ongoing: YESInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953526
Page 117 of 178
***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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.f Line/MH Number:
Date Location User Value Reason
Oct-16-2020 15:19:27
(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
Oct-16-2020 15:19:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
POSTMENOPAUSALInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-16-2020 15:19:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-16-2020 15:19:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953527
Page 118 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Aug-27-2020 12:32:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-27-2020 12:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-27-2020 12:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
57.8New Information
Aug-27-2020 12:32:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Weight 578 is
outside of Normal
Range 25 - 136 for
kg or 50 - 300 for
lb.
Aug-27-2020 12:32:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
578.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-27-2020 12:32:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-27-2020 12:32:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
157.5Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (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-2021-5683-0953528
Page 119 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5. Unit:
Date Location User Value Reason
Aug-27-2020 12:32:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-27-2020 12:34:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.3New Information
Aug-27-2020 12:32:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
233.0Initial Entry
7.a
Date Location User Value Reason
Aug-27-2020 12:32:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.5
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-27-2020 12:32:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-27-2020 12:32:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.5Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953529
Page 120 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7.a Unit:
Date Location User Value Reason
Aug-27-2020 12:32:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-27-2020 12:32:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953530
Page 121 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-27-2020 12:32:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-27-2020 12:32:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-27-2020 12:32:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-27-2020 12:32:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-27-2020 12:32:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-27-2020 12:32:44
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953531
Page 122 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-27-2020 12:32:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-27-2020 12:32:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-27-2020 12:32:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953532
Page 123 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-27-2020 12:33:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-27-2020 12:33:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
69585Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953533
Page 124 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 16:04:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 16:04:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 16:04:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 16:04:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-27-2020 16:04:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 16:04:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8J33Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953534
Page 125 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 16:04:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8J33Initial Entry
5.b
Date Location User Value Reason
Aug-27-2020 16:04:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8J34Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-27-2020 16:04:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8J34Initial Entry
5.c
Date Location User Value Reason
Aug-27-2020 16:05:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8J35Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-27-2020 16:05:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8J35Initial Entry
5.d
Date Location User Value Reason
Aug-27-2020 16:05:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRMR8Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (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-2021-5683-0953535
Page 126 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.d Sample ID
Date Location User Value Reason
Aug-27-2020 16:05:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPRMR8Initial Entry
5.e
Date Location User Value Reason
Aug-27-2020 16:05:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRMR9Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-27-2020 16:05:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPRMR9Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953536
Page 127 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 16:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 16:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020 16:05:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 16:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-27-2020 16:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 16:05:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8J2JInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953537
Page 128 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 16:05:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8J2JInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953538
Page 129 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-27-2020 12:34:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020 12:34:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020 12:34:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-27-2020 12:34:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020 11:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020 12:34:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-27-2020 12:34:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953539
Page 130 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Route:
Date Location User Value Reason
Aug-27-2020 12:34:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-27-2020 12:34:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-27-2020 12:34:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953540
Page 131 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-04-2020 05:25:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed As per site response
Sep-02-2020 12:11:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject was
inadvertently entered
into reactogenicity
group in Trial Max in
error. Data Correction
forms to be
completed.
Sep-02-2020 04:11:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened eDiary:
REACTOGENICITY
E-DIARY
COLLECTED FOR
THIS SUBJECT is
'No' however VAX 1
eDiary records are
available for the
subject. Please verify
and update. Else,
confirm in query
response
appropriately.
Aug-27-2020 12:35:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953541
Page 132 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-17-2020 13:09:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953542
Page 133 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020 13:10:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
2.a
Date Location User Value Reason
Sep-17-2020 13:10:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.8
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-17-2020 13:10:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-17-2020 13:10:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-17-2020 13:10:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (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-2021-5683-0953543
Page 134 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.a Temperature Location:
Date Location User Value Reason
Sep-17-2020 13:10:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953544
Page 135 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-17-2020 13:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-17-2020 13:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-17-2020 13:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-17-2020 13:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-17-2020 13:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-17-2020 13:10:42
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953545
Page 136 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-17-2020 13:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-17-2020 13:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-17-2020 13:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953546
Page 137 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020 13:09:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020 13:09:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020 13:09:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-17-2020 13:09:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-17-2020 13:09:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020 13:09:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1HD2Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953547
Page 138 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 13:09:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1HD2Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953548
Page 139 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-17-2020 13:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020 13:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020 13:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-17-2020 13:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/17/2020 09:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020 13:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-17-2020 13:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953549
Page 140 of 178
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Route:
Date Location User Value Reason
Sep-17-2020 13:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-17-2020 13:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-17-2020 13:11:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953550
Page 141 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020 09:54:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953551
Page 142 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 15:47:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 15:47:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020 15:48:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 15:47:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-15-2020 15:47:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020 15:48:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8JBSInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953552
Page 143 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 15:48:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8JBSInitial Entry
5.b
Date Location User Value Reason
Oct-15-2020 15:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8JBTInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020 15:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8JBTInitial Entry
5.c
Date Location User Value Reason
Oct-15-2020 15:48:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR8JBVInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-15-2020 15:48:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR8JBVInitial Entry
5.d
Date Location User Value Reason
Oct-15-2020 15:48:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSJLC9Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (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-2021-5683-0953553
Page 144 of 178
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.d Sample ID
Date Location User Value Reason
Oct-15-2020 15:48:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSJLC9Initial Entry
5.e
Date Location User Value Reason
Oct-15-2020 15:49:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSJLCBInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-15-2020 15:49:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSJLCBInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953554
Page 145 of 178
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021 16:23:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/12/2021Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953555
Page 146 of 178
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-12-2021 18:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021 18:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021 18:11:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-12-2021 18:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-12-2021 18:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/12/2021Initial Entry
5.a
Date Location User Value Reason
Mar-12-2021 18:11:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR9RT7Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953556
Page 147 of 178
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Mar-12-2021 18:11:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR9RT7Initial Entry
5.b
Date Location User Value Reason
Mar-12-2021 18:11:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS0875Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-12-2021 18:11:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS0875Initial Entry
5.c
Date Location User Value Reason
Mar-12-2021 18:11:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS0876Initial Entry
5.c Sample ID
Date Location User Value Reason
Mar-12-2021 18:11:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS0876Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953557
Page 148 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-05-2020 16:36:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-05-2020 16:35:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Nov-05-2020 16:35:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Nov-05-2020 16:35:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/4/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-05-2020 16:35:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953558
Page 149 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/4/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/31/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Dec-02-2020 09:46:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolve
d:
Nov/9/2020New Information
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953559
Page 150 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
4.a Was symptom present?
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCREA
SED COUGH
Symptom
Present:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUG
HInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953560
Page 151 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.c Symptoms:
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORT
NESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAINInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (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-2021-5683-0953561
Page 152 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Symptom
Present:YES
4.e Symptoms:
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW LOSS OF TA
STE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SM
ELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (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-2021-5683-0953562
Page 153 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHE
A
Symptom Present
:NOInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953563
Page 154 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.h Symptoms:
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITIN
G
Symptom Present
:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-05-2020 17:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Nov-05-2020 17:08:20
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Symptoms - Othe HEADACHInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953564
Page 155 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada) r: E
5.a Symptoms - Other Text:
Date Location User Value Reason
Nov-05-2020 17:08:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
5.b
Date Location User Value Reason
Nov-05-2020 17:08:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - Other: FATIGUEInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Nov-05-2020 17:08:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953565
Page 156 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-05-2020 16:37:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-05-2020 16:37:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-05-2020 16:37:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-05-2020 16:37:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Device Type:
Date Location User Value Reason
Nov-05-2020 16:37:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Trade Name:
Date Location User Value Reason
Nov-05-2020 16:37:52
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953566
Page 157 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
7. Test Result:
Date Location User Value Reason
Nov-05-2020 16:37:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Nov-05-2020 16:37:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Nov-05-2020 16:37:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953567
Page 158 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-05-2020 16:36:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-05-2020 16:36:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-05-2020 16:36:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-05-2020 16:36:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-05-2020 16:36:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/5/2020Initial Entry
5.a
Date Location User Value Reason
Nov-05-2020 16:36:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: CV02433Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953568
Page 159 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Nov-05-2020 16:36:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CV02433Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953569
Page 160 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-05-2020 16:38:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-05-2020 16:38:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-05-2020 16:38:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-05-2020 16:38:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SELF SWAB DONEInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953570
Page 161 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits
or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:EMERGEN
CY ROOM
Occurrence of Vi
sits or Contacts:NOInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953571
Page 162 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Conta
cts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (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-2021-5683-0953572
Page 163 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practit
ioner:URGENT CAR
E
Occurrence of
Visits or Conta
cts:YES
Number of Vis
its or Contact
s:
1Initial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.e
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practit
ioner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953573
Page 164 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits or
Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Nov-05-2020 16:39:19
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (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-2021-5683-0953574
Page 165 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0953575
Page 166 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/04/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Nov-05-2020 16:41:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Nov-05-2020 16:41:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Nov-05-2020 16:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Transcription Error
Nov-05-2020 16:41:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
0Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953576
Page 167 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/02/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-02-2020 09:42:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/2/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-02-2020 09:42:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953577
Page 168 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/02/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-02-2020 09:43:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-02-2020 09:43:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-02-2020 09:43:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-02-2020 09:43:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-02-2020 09:43:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/2/2020Initial Entry
5.a
Date Location User Value Reason
Dec-02-2020 09:43:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR9D6CInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953578
Page 169 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/02/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Dec-02-2020 09:43:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR9D6CInitial Entry
5.b
Date Location User Value Reason
Dec-02-2020 09:44:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR9D6DInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-02-2020 09:44:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR9D6DInitial Entry
5.c
Date Location User Value Reason
Dec-02-2020 09:44:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR9D6FInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-02-2020 09:44:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR9D6FInitial Entry
5.d
Date Location User Value Reason
Dec-02-2020 09:44:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS671XInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953579
Page 170 of 178
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/02/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.d Sample ID
Date Location User Value Reason
Dec-02-2020 09:44:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS671XInitial Entry
5.e
Date Location User Value Reason
Dec-02-2020 09:44:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS671YInitial Entry
5.e Sample ID
Date Location User Value Reason
Dec-02-2020 09:44:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS671YInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953580
Page 171 of 178
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-15-2020 09:55:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-15-2020 09:55:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-15-2020 09:55:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953581
Page 172 of 178
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-19-2021 09:33:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/20/2021Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953582
Page 173 of 178
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-22-2021 11:26:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed to
have received only placebo at
Vaccination 1/2Changed
Information
Feb-19-2021 09:33:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT willing to retur
n for Vaccination 3 OR otherwise
not eligibleInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953583
Page 174 of 178
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-12-2021 17:19:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/22/2021Changed
Information
Feb-19-2021 09:33:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/20/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Feb-22-2021
16:21:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_35
Feb-22-2021
11:26:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dChanged data per query
Feb-22-2021
03:10:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7348761;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Feb-19-2021 ACV0PFEINFP6000 DataInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0953584
Page 175 of 178
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
09:33:57
(UTC-05:00)
Eastern Time
(US &
Canada)Entry
:
ASSE
SS EL
IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ON
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0953585
Page 176 of 178
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-15-2020 09:55:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-27-2020 12:33:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-27-2020 12:30:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-06-2020 03:42:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-05-2020 16:36:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Nov-05-2020 16:26:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened HOLDS: Nasal
swab barcode
CV02433 was
received by the lab
for COVID_A.
Please review and
update or submit
and updated SCF.
Oct-15-2020 09:55:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/15/2020Initial Entry
Aug-27-2020 12:33:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
Aug-27-2020 12:30:18
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/27/2020Initial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953586
Page 177 of 178
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953587
Page 178 of 178
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1077 Site Name: (1077) Regional Clinical Research, Inc
Subject No: 10771137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-23-2020 08:46:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae30d2\Final\Final On: 01-Apr-2021 04:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953588