Document text
Page 1 of 278
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791607
Page 2 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/12/2020
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791608
Page 3 of 278
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11121301]
2.Birth Date: /1972
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791609
Page 4 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791610
Page 5 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791611
Page 6 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791612
Page 7 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Hypertension]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791613
Page 8 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What is
the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791614
Page 9 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Oct/12/2020
2.Weight: [170.0]
3.Unit: LB
4.Height: [71.0]
5.Unit: in
6.Body Mass Index: [23.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791615
Page 10 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/12/2020
2.Randomization Number: [106682]
3.Randomization Group: [ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791616
Page 11 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/12/2020
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 [BPXS83]
5.bSample ID [BJ4PXW]
5.cSample ID [BJ4PXX]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791617
Page 12 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/12/2020
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 [BPXS7L]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791618
Page 13 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: Oct/12/2020 17:33
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
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791619
Page 14 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791620
Page 15 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791621
Page 16 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Nov/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791622
Page 17 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/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 [BMB9RS]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791623
Page 18 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: Nov/2/2020 13:42
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
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791624
Page 19 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/4/2021
2.Erroneous Visit
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791625
Page 20 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[samples collected under convalescent visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791626
Page 21 of 278
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/4/2021 Comments
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791627
Page 22 of 278
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791628
Page 23 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/28/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791629
Page 24 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/28/2020
2.Date of First Symptom Started: Nov/28/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/19/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
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? YES
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? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Nausea]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791630
Page 25 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.bSymptoms - Other Text: [Nasal discharge]
5.cSymptoms - Other Text: [Nasal congestion]
5.dSymptoms - Other Text: [New or increased sputum production]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791631
Page 26 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of Co
llectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
1.Dec/19/202
0 SWABBED M
ATERIAL NASOPHARYNX SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791632
Page 27 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/19/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: IPSUM COV-19 IDX ASSAY Comments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [ ] Comments
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791633
Page 28 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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/29/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV02743]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791634
Page 29 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 swabbed performed]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791635
Page 30 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791636
Page 31 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Dec/8/2020 NO
Discharge Date:
Dec/9/2020
Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0791637
Page 32 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Dec/8/2020
4.Ongoing? NO
Discharge Date:
Dec/9/2020
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791638
Page 33 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatment TreatmentStart D
ateForm Instanc
e
1.1 YES HIGH FLOW OXYGEN
THERAPY HIGH FLOW OXYGEN
THERAPY Dec/8/2
020 Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0791639
Page 34 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1] Comments
2.Concomitant Non-drug Treatment
Pre-specified:YES Comments
3.Treatment: HIGH FLOW OXYGEN THERAPY Comments
4.Treatment: [HIGH FLOW OXYGEN THERAPY] Comments
5.Start Date: Dec/8/2020 Comments
6.Ongoing? NO
End Date:
Dec/9/2020Comments
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791640
Page 35 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?YES
Respiratory Illness Diagnosis:
[Pneumonia]
Date of Diagnosis:
Dec/8/2020
3.Toxicity Grade: 3
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791641
Page 36 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791642
Page 37 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791643
Page 38 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category fo
r Lab TestVendor NameCollecti
on Date
:Specim
en TypeLab ResultForm Insta
nce
1.CLINICAL
CHEMISTR
Y Wellstar Kennestone Hospital,677
Church Street,Marietta,GA 30060-
1101 Dec/8/2
020 BLOO
D Sponsor-Def
ined Identifi
erTest:Res
ult:
329 C Reactive Prote
in_PX329 [ ]
30 Alanine Aminot
ransferase_PX3
0 [ ]
28 Aspartate Amin
otransferase_PX
28 [ ]
35 Alkaline Phosph
atase_PX35 [ ]
21 Bilirubin_PX21 [ ]
47 Blood Urea Nitr
ogen_PX47 22
48 Creatinine_PX4
8 1.06
Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0791644
Page 39 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Wellstar Kennestone Hospital,677 Church Street,Marietta,GA 30060-1101]
3.Collection Date: Dec/8/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791645
Page 40 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [22]
Not Done:
LNMT Low
[6]
High
[20]
Unit
mg/dL
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791646
Page 41 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.06]
Not Done:
LNMT Low
[0.7]
High
[1.2]
Unit
mg/dL
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791647
Page 42 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category fo
r Lab TestVendor Name (DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.HEMATOL
OGY Wellstar Kennestone Hospital,677 Ch
urch Street,Marietta GA 30060-1101 Dec/8/20
20 BLOOD
Sponsor-Defi
ned IdentifierTest:Res
ult:
1 Hemoglobi
n_PX1 17.3
2 Hematocrit
_PX2 49.1
3 Erythrocyte
s_PX3 [ ]
5 Platelets_P
X5 197
7 Leukocytes
_PX7 [ ]
608 Neutrophils
_PX608 4.86
609 Eosinophils
_PX609 0.04
612 Monocytes
_PX612 0.83
610 Basophils_
PX610 0.03
611 Lymphocyt
es_PX611 2.81
Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0791648
Page 43 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Wellstar Kennestone Hospital,677 Church Street,Marietta GA 30060-1101]
3.Collection Date: Dec/8/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [17.3]
Not Done:
LNMT Low
[13.5]
High
[17.5]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [49.1]
Not Done:
LNMT Low
[39.0]
High
[50.0]
Unit
%
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791649
Page 44 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [197]
Not Done:
LNMT Low
[150]
High
[450]
Unit
10^9/L
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791650
Page 45 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [4.86]
Not Done:
LNMT Low
[1.70]
High
[7.00]
Unit
10^9/L
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.04]
Not Done:
LNMT Low
[0.10]
High
[0.50]
Unit
10^9/L
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.83]
Not Done:
LNMT Low
[0.30]
High
[0.90]
Unit
10^9/L
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791651
Page 46 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.03]
Not Done:
LNMT Low
[0.00]
High
[0.30]
Unit
10^9/L
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [2.81]
Not Done:
LNMT Low
[1.50]
High
[4.00]
Unit
10^9/L
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791652
Page 47 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
1.Dec/8/2020 Record Identifier: Systolic: Diastolic:
1 120 83 Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0791653
Page 48 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [120]
Diastolic: [83]
Respiratory Rate in
respirations/minute:[27]
Heart Rate in beats/minute: [77]
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(b) (4)
FDA-CBER-2021-5683-0791654
Page 49 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Date: Vital Signs Details Form Instance
1.Dec/8/2020 Record Identifier: Oxygen Saturation
1 99.0 Repeating Pages
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791655
Page 50 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/8/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [99.0]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791656
Page 51 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791657
Page 52 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791658
Page 53 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applica
ble Repeating
Pages
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791659
Page 54 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791660
Page 55 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Dec/8/2020 CHEST X-RAY NORMAL Repeating Pages
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791661
Page 56 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Dec/8/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: NORMAL
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791662
Page 57 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Jan/04/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/4/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791663
Page 58 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Jan/04/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/4/2021
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 [BS39SJ]
5.bSample ID [BS39SK]
5.cSample ID [BRC9K0]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791664
Page 59 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791665
Page 60 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791666
Page 61 of 278
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# CategoryAE Identifi
erAdverse Eve
ntStart DateIs the Adverse Event Still On
goingForm Instance
1. DELETED ADVERSE EVE
NT 1 Pneumonia Dec/8/2020 15:
00 NO
End Date Time:
Dec/18/2020 08:00
Repeating
Pages
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791667
Page 62 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pneumonia ]
4.Start Date Time: Dec/8/2020 15:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/18/2020 08:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[COVID-19 illness ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791668
Page 63 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
*** THIS REPEATING FORM HAS BEEN DELETED ***
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791669
Page 64 of 278
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791670
Page 65 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791671
Page 66 of 278
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791672
Page 67 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: //
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791673
Page 68 of 278
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791674
Page 69 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791675
Page 70 of 278
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791676
Page 71 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791677
Page 72 of 278
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791678
Page 73 of 278
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791679
Page 74 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791680
Page 75 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791681
Page 76 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791682
Page 77 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791683
Page 78 of 278
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791684
Page 79 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791685
Page 80 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791686
Page 81 of 278
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Jan/4/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791687
Page 82 of 278
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791688
Page 83 of 278
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only placebo
at Vaccination 1/2
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791689
Page 84 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791690
Page 85 of 278
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/1/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791691
Page 86 of 278
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791692
Page 87 of 278
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791693
Page 88 of 278
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/11/2021
2.Erroneous Visit
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791694
Page 89 of 278
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/11/2021Comments
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791695
Page 90 of 278
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791696
Page 91 of 278
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/11/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791697
Page 92 of 278
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/11/2021
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 [BRMY6H]
5.bSample ID [BSN3TL]
5.cSample ID [BSN3TM]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791698
Page 93 of 278
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/11/2021
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 [BRMY6P]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791699
Page 94 of 278
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/11/2021 17:58
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791700
Page 95 of 278
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791701
Page 96 of 278
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/3/2021
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 [BR5WZH]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791702
Page 97 of 278
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/3/2021 14:17
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791703
Page 98 of 278
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791704
Page 99 of 278
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791705
Page 100 of 278
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791706
Page 101 of 278
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791707
Page 102 of 278
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791708
Page 103 of 278
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791709
Page 104 of 278
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791710
Page 105 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Jan/4/2021
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791711
Page 106 of 278
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791712
Page 107 of 278
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Nathan Segall Approved Mar-06-2021 10:59:32 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NathanSegall, 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.
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4)
FDA-CBER-2021-5683-0791713
Page 108 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormOct-12-2020 18:40:05 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791714
Page 109 of 278
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Jan-04-2021 18:14:34 (UTC-05:00) Eastern Time
(US & Canada)entered in error, visit not occurred yet
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791715
Page 110 of 278
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormMar-03-2021 19:16:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791716
Page 111 of 278
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Mar-03-2021 19:16:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791717
Page 112 of 278
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Mar-03-2021 19:16:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791718
Page 113 of 278
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Mar-03-2021 19:16:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791719
Page 114 of 278
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Mar-03-2021 19:16:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791720
Page 115 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-22-2020 12:16:09 (UTC-05:00) Eastern Time
(US & Canada)
FormNov-28-2020 20:46:44 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791721
Page 116 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-22-2020 12:16:09 (UTC-05:00) Eastern Time
(US & Canada)
1Nov-28-2020 20:46:44 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791722
Page 117 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-22-2020 12:16:09 (UTC-05:00) Eastern Time
(US & Canada)
2Nov-28-2020 20:46:44 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791723
Page 118 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-22-2020 12:16:09 (UTC-05:00) Eastern Time
(US & Canada)
3Nov-28-2020 20:46:44 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791724
Page 119 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-22-2020 12:16:09 (UTC-05:00) Eastern Time
(US & Canada)
4Nov-28-2020 20:46:44 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791725
Page 120 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Dec-22-2020 12:16:09 (UTC-05:00) Eastern Time
(US & Canada)
5Nov-28-2020 20:46:44 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791726
Page 121 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Dec-22-2020 12:16:09 (UTC-05:00) Eastern Time
(US & Canada)
6Nov-28-2020 20:46:44 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791727
Page 122 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
7Dec-22-2020 12:16:09 (UTC-05:00) Eastern Time
(US & Canada)
7Nov-28-2020 20:46:44 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791728
Page 123 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
8Dec-22-2020 12:16:09 (UTC-05:00) Eastern Time
(US & Canada)
8Nov-28-2020 20:46:44 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791729
Page 124 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
9Dec-22-2020 12:16:09 (UTC-05:00) Eastern Time
(US & Canada)
9Nov-28-2020 20:46:44 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791730
Page 125 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormJan-04-2021 14:57:00 (UTC-05:00) Eastern Time
(US & Canada)
FormDec-22-2020 13:28:53 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791731
Page 126 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Jan-04-2021 14:57:00 (UTC-05:00) Eastern Time
(US & Canada)
1Dec-22-2020 13:28:53 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791732
Page 127 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Jan-04-2021 14:57:00 (UTC-05:00) Eastern Time
(US & Canada)
2Dec-22-2020 13:28:53 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791733
Page 128 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Jan-04-2021 14:57:00 (UTC-05:00) Eastern Time
(US & Canada)
3Dec-22-2020 13:28:53 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791734
Page 129 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Jan-04-2021 14:57:00 (UTC-05:00) Eastern Time
(US & Canada)
4Dec-22-2020 13:28:53 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791735
Page 130 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Jan-04-2021 14:57:00 (UTC-05:00) Eastern Time
(US & Canada)
5Dec-22-2020 13:28:53 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791736
Page 131 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Jan-04-2021 14:57:00 (UTC-05:00) Eastern Time
(US & Canada)
6Dec-22-2020 13:28:53 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791737
Page 132 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-22-2020 13:14:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791738
Page 133 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-22-2020 13:14:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791739
Page 134 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-22-2020 13:14:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791740
Page 135 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-22-2020 13:14:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791741
Page 136 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-22-2020 13:14:24 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791742
Page 137 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-22-2020 13:29:12 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791743
Page 138 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-22-2020 13:29:12 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791744
Page 139 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-22-2020 13:29:12 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791745
Page 140 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-22-2020 13:29:12 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791746
Page 141 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormDec-22-2020 13:29:31 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791747
Page 142 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Dec-22-2020 13:29:31 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791748
Page 143 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Dec-22-2020 13:29:31 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791749
Page 144 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Dec-22-2020 13:29:31 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791750
Page 145 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Dec-22-2020 13:29:31 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791751
Page 146 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Dec-22-2020 13:29:31 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791752
Page 147 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6Dec-22-2020 13:29:31 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791753
Page 148 of 278
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormFeb-15-2021 08:20:41 (UTC-05:00) Eastern Time
(US & Canada)
FormFeb-11-2021 21:35:13 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791754
Page 149 of 278
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Feb-15-2021 08:20:41 (UTC-05:00) Eastern Time
(US & Canada)
1Feb-11-2021 21:35:13 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791755
Page 150 of 278
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormFeb-11-2021 21:35:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791756
Page 151 of 278
***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, Signed, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Nathan Segall Approved Mar-06-2021 10:59:32 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NathanSegall, 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-24-2021 19:20:07 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nathan Segall Approved Feb-17-2021 09:48:11 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NathanSegall, 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-15-2021 08:20:41 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nathan Segall Approved Feb-12-2021 13:59:17 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791757
Page 152 of 278
***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, Signed, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Affidavit:
By my dated signature below, I, NathanSegall, 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-11-2021 21:35:01 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nathan Segall Approved Feb-02-2021 13:57:18 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NathanSegall, 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-01-2021 14:52:28 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nathan Segall Approved Jan-09-2021 09:20:08 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NathanSegall, 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 Dec-22-2020 17:16:04 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791758
Page 153 of 278
***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, Signed, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Affidavit:
N/A
Nathan Segall Approved Dec-22-2020 13:54:47 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NathanSegall, 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 Dec-22-2020 12:16:09 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nathan Segall Approved Dec-17-2020 09:44:11 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NathanSegall, 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 Dec-16-2020 10:02:48 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nathan Segall Approved Dec-15-2020 09:46:58 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791759
Page 154 of 278
***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, Signed, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Affidavit:
By my dated signature below, I, NathanSegall, 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 Dec-14-2020 08:35:36 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nathan Segall Approved Dec-09-2020 18:37:31 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NathanSegall, 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-28-2020 20:40:01 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Nathan Segall Approved Nov-16-2020 16:22:47 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, NathanSegall, 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.
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791760
Page 155 of 278
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-12-2020 18:39:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-12-2020 18:39:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791761
Page 156 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-12-2020 18:39:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/12/2020Initial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791762
Page 157 of 278
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-12-2020 18:39:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11121301Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-12-2020 18:39:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1972Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-12-2020 18:39:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-12-2020 18:39:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-12-2020 18:39:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791763
Page 158 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-12-2020 18:39:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791764
Page 159 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-12-2020 18:40:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-12-2020 18:40:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-12-2020 18:40:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791765
Page 160 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.a
Date Location User Value Reason
Oct-12-2020 18:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Hypertension
Start Date: UNK/UNK/20
05
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-12-2020 18:40:40
(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
Oct-12-2020 18:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-12-2020 18:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-12-2020 18:40:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791766
Page 161 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-12-2020 18:40:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be HIV
POSITIVEInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791767
Page 162 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Oct-12-2020 18:41:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-12-2020 18:41:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
170.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-12-2020 18:41:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-12-2020 18:41:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
71.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-12-2020 18:41:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-12-2020 18:41:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23.7Initial Entry
7.a
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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-2021-5683-0791768
Page 163 of 278
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-12-2020 18:41:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.6
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-12-2020 18:41:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-12-2020 18:41:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.6Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-12-2020 18:41:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-12-2020 18:41:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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-2021-5683-0791769
Page 164 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-12-2020 18:41:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-12-2020 18:41:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
106682Initial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791770
Page 165 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 18:57:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 18:57:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020 18:57:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-12-2020 18:57:23
(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.
Oct-12-2020 18:57:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/12/2020Initial Entry
5.a
Date Location User Value Reason
Oct-12-2020 18:57:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXS83Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-12-2020 18:57:40
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
BPXS83Initial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791771
Page 166 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(US & Canada)
5.b
Date Location User Value Reason
Oct-12-2020 18:57:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BJ4PXWInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-12-2020 18:57:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BJ4PXWInitial Entry
5.c
Date Location User Value Reason
Oct-12-2020 18:58:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BJ4PXXInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-12-2020 18:58:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BJ4PXXInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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-2021-5683-0791772
Page 167 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 18:41:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 18:41:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020 18:41:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-12-2020 18:41:43
(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-12-2020 18:41:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/12/2020Initial Entry
5.a
Date Location User Value Reason
Oct-12-2020 18:41:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPXS7LInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-12-2020 18:41:51
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
BPXS7LInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791773
Page 168 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(US & Canada)
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0791774
Page 169 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-12-2020 18:42:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-12-2020 18:42:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-12-2020 18:42:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-12-2020 18:42:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020 17:33Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-12-2020 18:42:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-12-2020 18:42:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791775
Page 170 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-12-2020 18:42:09
(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
Oct-12-2020 18:42:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-12-2020 18:42:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791776
Page 171 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-12-2020 18:42:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791777
Page 172 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-02-2020 15:01:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/2/2020Initial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791778
Page 173 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Nov-02-2020 15:01:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/2/2020Initial Entry
2.a
Date Location User Value Reason
Nov-02-2020 15:01:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.6
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-02-2020 15:01:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-02-2020 15:01:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
97.6Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-02-2020 15:01:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-02-2020 15:01:53
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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-2021-5683-0791779
Page 174 of 278
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(US & Canada)
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0791780
Page 175 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-02-2020 15:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-02-2020 15:02:03
(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-02-2020 15:02:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-02-2020 15:02:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-02-2020 15:02:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/2/2020Transcription Error
Nov-02-2020 15:02:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Deleted Close Auto Query
Nov-02-2020 15:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-02-2020 15:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Date of Assessment is
a future date relative
to when it was
entered. Please
correct.
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791781
Page 176 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Nov-02-2020 15:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of Collection
09/Dec/2020 is greater
than Date of Visit
02/Nov/2020. Please
review and update as
appropriate, else
clarify.
Nov-02-2020 15:02:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/9/2020Initial Entry
5.a
Date Location User Value Reason
Nov-02-2020 15:02:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMB9RSInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-02-2020 15:02:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BMB9RSInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791782
Page 177 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-02-2020 15:03:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-02-2020 15:03:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-02-2020 15:03:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-02-2020 15:03:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/2/2020 13:42Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-02-2020 15:03:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-02-2020 15:03:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791783
Page 178 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Nov-02-2020 15:03:01
(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
Nov-02-2020 15:03:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Nov-02-2020 15:03:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791784
Page 179 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User ValueReason
Jan-06-2021
01:51:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedAs per site confirmation -
updated PD tracker
Jan-06-2021
00:09:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies query
Jan-05-2021
08:27:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Ans
weredconfirm out of window due to
Covid-19 diagnosis
Jan-05-2021
08:27:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredChanged data per query
Jan-05-2021
04:52:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
2: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 28 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately.
Jan-05-2021
04:44:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Op
enedDM: The treatment period is
defined as 1st vaccination visit
through the 1-month post
vaccination visit after the 2nd
vaccination. Please complete
treatment disposition CRF and
update date of EOT to match
date of visit at visit 3.
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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) (4)
FDA-CBER-2021-5683-0791785
Page 180 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Jan-04-2021
18:13:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Jan/4/
2021Initial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0791786
Page 181 of 278
***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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-04-2021 18:14:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-04-2021 18:14:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-04-2021 18:14:06
(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
Jan-04-2021 18:14:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
samples collected under convalescent
visitInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791787
Page 182 of 278
***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, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-05-2021 01:41:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Deleted Query is invalid or
does not apply
Jan-04-2021 18:14:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Erroneous Visit is
marked, but date of
visit is entered. Please
check whether other
assessments are
performed at this visit.
Jan-04-2021 14:54:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/4/2021Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Jan-04-2021 18:14:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791788
Page 183 of 278
***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, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-03-2021 19:16:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Mar-03-2021 19:15:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Mar-03-2021 19:15:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-03-2021 19:16:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Mar-03-2021 19:15:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Mar-03-2021 19:15:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-03-2021 19:16:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Mar-03-2021 19:15:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-03-2021 19:15:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Mar-03-2021 19:15:07
(UTC-05:00) Eastern TimeACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791789
Page 184 of 278
***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, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(US & Canada) barcodes are entered.
Please review and
correct as appropriate.
Mar-03-2021 19:15:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/3/2021Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Mar-03-2021 19:16:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791790
Page 185 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-30-2020 14:38:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-30-2020 04:55:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened 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-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-28-2020 20:40:00
(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-28-2020 20:40:00
(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-28-2020 20:40:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/28/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-28-2020 20:40:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791791
Page 186 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/28/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/28/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-04-2021 18:55:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolved:
Dec/19/2020New Information
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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-2021-5683-0791792
Page 187 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASE
D COUGH
Symptom Pr
esent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREASED S
HORTNESS OF BREAT
H
Symptom
Present:NOInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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-2021-5683-0791793
Page 188 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
4.c Symptoms:
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORTNES
S OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASED
MUSCLE PAIN
Symptom
Present:YESInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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-2021-5683-0791794
Page 189 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
4.e Symptoms:
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCLE P
AINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW LOSS OF TAST
E OR SMELL
Symptom P
resent:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Feb-24-2021 19:20:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCREASED
SORE THROAT
Symptom
Present:YESTranscription Error
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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-2021-5683-0791795
Page 190 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW OR INCREASED
SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE THR
OATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Mar-02-2021 11:28:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-24-2021 19:20:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Feb-24-2021 19:20:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESTranscription Error
Feb-24-2021 16:44:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Per source COVID
ILL Visit & T-Health
visit states Yes to
"new or increased sore
throat". Please verify
and reconcile.
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791796
Page 191 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
4.h Symptoms:
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-28-2020 20:42:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Nov-28-2020 20:42:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - Other: NauseaInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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-2021-5683-0791797
Page 192 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF Audit
Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Nov-28-2020 20:42:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NauseaInitial Entry
5.b
Date Location User Value Reason
Nov-28-2020 20:43:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - Other: Nasal dischargeInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Nov-28-2020 20:43:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nasal dischargeInitial Entry
5.c
Date Location User Value Reason
Nov-28-2020 20:43:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - Other
:Nasal congestio
nInitial Entry
5.c Symptoms - Other Text:
Date Location User Value Reason
Nov-28-2020 20:43:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nasal congestionInitial Entry
5.d
Date Location User Value Reason
Nov-28-2020 20:44:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms -
Other:New or increased sputu
m productionInitial Entry
5.d Symptoms - Other Text:
Date Location User Value Reason
Nov-28-2020 20:44:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
New or increased sputum productionInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791798
Page 193 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Dec-22-2020 12:16:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791799
Page 194 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Dec-22-2020 12:16:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/19/2020Initial Entry
Dec-22-2020 12:16:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-28-2020 20:46:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Specimen Type:
Date Location User Value Reason
Dec-22-2020 12:16:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
Dec-22-2020 12:16:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-28-2020 20:46:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Dec-22-2020 12:16:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
Dec-22-2020 12:16:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-28-2020 20:46:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791800
Page 195 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Dec-22-2020 12:16:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDROM
E CORONAVIRUS 2Initial Entry
Dec-22-2020 12:16:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-28-2020 20:46:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Device Type:
Date Location User Value Reason
Dec-22-2020 12:16:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
Dec-22-2020 12:16:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-28-2020 20:46:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Trade Name:
Date Location User Value Reason
Dec-22-2020 12:16:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IPSUM COV-19 IDX ASSAYInitial Entry
Dec-22-2020 12:16:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-28-2020 20:46:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
7. Test Result:
Date Location User Value Reason
Dec-22-2020 12:16:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791801
Page 196 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Dec-22-2020 12:16:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-28-2020 20:46:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Dec-22-2020 12:16:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-28-2020 20:46:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Dec-22-2020 12:16:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-28-2020 20:46:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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-2021-5683-0791802
Page 197 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: 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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-30-2020 14:38:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-30-2020 14:38:08
(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-30-2020 14:38:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-30-2020 14:38:08
(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-30-2020 14:38:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/29/2020Initial Entry
5.a
Date Location User Value Reason
Nov-30-2020 14:38:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: CV02743Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-30-2020 14:38:21
(UTC-05:00) Eastern TimeACV0PFEINFP6000 Data Entry:
CV02743Initial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791803
Page 198 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: 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: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(US & Canada)
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0791804
Page 199 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-28-2020 20:47:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-28-2020 20:47:04
(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-28-2020 20:47:04
(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-28-2020 20:47:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
self swabbed performedInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791805
Page 200 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.a
Date Location User Value Reason
Nov-28-2020 20:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIAL
IST
Occurrence of Visits or
Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-28-2020 20:47:16
(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-28-2020 20:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Dec-16-2020 10:02:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:EMERGENCY R
OOM
Occurrence of Vi
sits or Contacts:YES
Number of Visit
s or Contacts:
1Transcription Error
Nov-28-2020 20:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner
:EMERGENC
Y ROOM
Occurrence of Visits
or Contacts:NOInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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-2021-5683-0791806
Page 201 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-28-2020 20:47:16
(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
Dec-16-2020 10:02:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Number of Visits or Contacts:
1Transcription Error
Nov-28-2020 20:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Nov-28-2020 20:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:PRIMARY CAR
E PHYSICIAN
Occurrence of Vis
its or Contacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-28-2020 20:47:16
(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-28-2020 20:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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-2021-5683-0791807
Page 202 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Nov-28-2020 20:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: URGENT
CARE
Occurrence of Visits or
Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-28-2020 20:47:16
(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-28-2020 20:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Nov-28-2020 20:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitio
ner:TELEPHONE C
ONSULTATION
Occurrence of Vi
sits or Contacts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Nov-28-2020 20:47:16
(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-28-2020 20:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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-2021-5683-0791808
Page 203 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Nov-28-2020 20:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or Con
tacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Nov-28-2020 20:47:16
(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-28-2020 20:47:16
(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
Dec-14-2020 08:35:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Has the subject been in intensive car
e due to potential COVID-19 illness
?
NONew Information
Nov-28-2020 20:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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-2021-5683-0791809
Page 204 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: HOSPITALIZATION DETAILS - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Dec-14-2020 08:41:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791810
Page 205 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Dec-14-2020 08:41:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Dec-14-2020 08:41:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HOSPITALInitial Entry
3. Admission Date:
Date Location User Value Reason
Dec-14-2020 08:41:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/8/2020Initial Entry
4. Ongoing?
Date Location User Value Reason
Dec-14-2020 08:41:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Discharge Date:
Dec/9/2020Initial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791811
Page 206 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: RESPIRATORY TREATMENT - Audit Trail
Form Version: 06-Jul-2020 21:53 Form Status:
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Jan-04-2021 14:57:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791812
Page 207 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: RESPIRATORY TREATMENT - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. What is the treatment Identifier?
Date Location User Value Reason
Jan-04-2021 14:57:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
Jan-04-2021 14:57:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-22-2020 13:28:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Concomitant Non-drug Treatment Pre-specified:
Date Location User Value Reason
Jan-04-2021 14:57:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
YESInitial Entry
Jan-04-2021 14:57:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-22-2020 13:28:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Treatment:
Date Location User Value Reason
Jan-04-2021 14:57:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HIGH FLOW OXYGEN THERAPYInitial Entry
Jan-04-2021 14:57:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-22-2020 13:28:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Treatment:
Date Location User Value Reason
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791813
Page 208 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: RESPIRATORY TREATMENT - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Jan-04-2021 14:57:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
HIGH FLOW OXYGEN THERAPYInitial Entry
Jan-04-2021 14:57:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-22-2020 13:28:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Start Date:
Date Location User Value Reason
Jan-04-2021 14:57:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/8/2020Initial Entry
Jan-04-2021 14:57:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-22-2020 13:28:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6. Ongoing?
Date Location User Value Reason
Jan-04-2021 14:57:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/9/2020Initial Entry
Jan-04-2021 14:57:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-22-2020 13:28:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791814
Page 209 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Nov-28-2020 20:47:33
(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
Jan-02-2021 14:49:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 1: Closed Response satisfies
query
Dec-31-2020 18:01:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Dec-31-2020 18:01:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Respiratory Illness Diagnosis:
Pneumonia
Date of Diagnosis:
Dec/8/2020Changed Information
Dec-31-2020 14:35:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Salim
BouguermouhQuery 1: Opened Clin: Please per CRF
COMPLETION
REQUIREMENTS
FOR INFORM Section
8.33.3. DO NOT
enter/update diagnosis
due to central lab
testing results. Please
enter only
PNEUMONIA. Please
remove "(due to
Covid-19)"
Dec-16-2020 10:11:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Respiratory Illness Diagnosis:
Pneumonia due to Covid-19New Information
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0791815
Page 210 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Diagnosis:
Dec/8/2020
Nov-28-2020 20:47:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Nov-28-2020 20:47:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791816
Page 211 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: ILLNESS DETAILS - SEVERE - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Dec-22-2020 13:14:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Subcategory of Clinical Event:
Date Location User Value Reason
Dec-22-2020 13:14:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Was a diagnosis obtained?
Date Location User Value Reason
Dec-22-2020 13:14:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Toxicity Grade:
Date Location User Value Reason
Dec-22-2020 13:14:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791817
Page 212 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - Audit
Trail
Form Version: 10-Oct-2020 15:58 Form Status:
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791818
Page 213 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
CLINICAL CHEMISTRYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Jan-07-2021 00:49:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Jan-05-2021 15:47:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Transcription Error
Jan-05-2021 15:47:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Wellstar Kennestone Hospital,677 C
hurch Street,Marietta,GA 30060-110
1Transcription Error
Jan-05-2021 13:16:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Opened DM :A carriage return
is still being
identified, please do
not press enter key,
just type lab name all
in single line with
comma separated.
Jan-05-2021 02:42:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Query closed data has
been updated
Jan-04-2021 14:53:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed Information
Jan-04-2021 14:53:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Wellstar Kennestone Hospital,677 C
hurch Street
Marietta, GA 30060-1101Changed Information
Jan-04-2021 14:33:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened DM :A carriage return
is identified, please do
not press enter key,
just type lab name all
in single line with
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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-2021-5683-0791819
Page 214 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
comma separated.
Dec-24-2020 03:29:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as data
updated.
Dec-23-2020 07:42:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Dec-23-2020 07:42:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Wellstar Kennestone Hospital
677 Church Street
Marietta, GA 30060-1101Transcription Error
Dec-23-2020 05:04:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened DM Query:
Laboratory Name
provided. Please
consider to update
Laboratory Address.
Thank you.
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Wellstar Kennestone HospitalInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/8/2020Initial Entry
4. Specimen Type:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:329
Test:: C Reactive Protei
n_PX329
Result::Initial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (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-2021-5683-0791820
Page 215 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Not Done:: NOT DONE
Lab Normal Rang
e:
5.a Sponsor ID:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
329Initial Entry
5.a Test:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
C Reactive Protein_PX329Initial Entry
5.a Not Done:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.b
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:30
Test:: Alanine Aminotran
sferase_PX30
Result::
Not Done:: NOT DONE
Lab Normal Ra
nge:Initial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791821
Page 216 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.b Sponsor ID:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30Initial Entry
5.b Test:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Alanine Aminotransferase_PX30Initial Entry
5.b Not Done:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.c
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:28
Test:: Aspartate Aminotra
nsferase_PX28
Result::
Not Done:: NOT DONE
Lab Normal Ra
nge:Initial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791822
Page 217 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.c Sponsor ID:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28Initial Entry
5.c Test:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aspartate Aminotransferase_PX28Initial Entry
5.c Not Done:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.d
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:35
Test:: Alkaline Phosphat
ase_PX35
Result::
Not Done:: NOT DONE
Lab Normal Rang
e:Initial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791823
Page 218 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Sponsor ID:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
35Initial Entry
5.d Test:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Alkaline Phosphatase_PX35Initial Entry
5.d Not Done:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.e
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Ident
ifier:21
Test:: Bilirubin_PX
21
Result::
Not Done:: NOT DONE
Lab Normal Range:Initial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791824
Page 219 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.e Sponsor ID:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
21Initial Entry
5.e Test:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Bilirubin_PX21Initial Entry
5.e Not Done:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
5.f
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:47
Test:: Blood Urea Nitrog
en_PX47
Result:: 22
Not Done::
Lab Normal Ran
ge:Low
6
High
20
Unit
mg/dLInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791825
Page 220 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.f Sponsor ID:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
47Initial Entry
5.f Test:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Blood Urea Nitrogen_PX47Initial Entry
5.f Result:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
22Initial Entry
5.f LNMT
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Low
6
High
20
Unit
mg/dLInitial Entry
5.g
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defined Iden
tifier:48
Test:: Creatinine_P
X48
Result:: 1.06
Not Done::Initial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791826
Page 221 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY - eCRF
Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Lab Normal Range: Low
0.7
High
1.2
Unit
mg/dL
5.g Sponsor ID:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
48Initial Entry
5.g Test:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Creatinine_PX48Initial Entry
5.g Result:
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1.06Initial Entry
5.g LNMT
Date Location User Value Reason
Dec-22-2020 13:16:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Low
0.7
High
1.2
Unit
mg/dLInitial Entry
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791827
Page 222 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - Audit
Trail
Form Version: 10-Oct-2020 16:02 Form Status:
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Dec-22-2020 13:13:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3dfc\Final\Final On: 01-Apr-2021 04:42 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0791828
Page 223 of 278
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Nov/28/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1112 Site Name: (1112) Clinical Research Atlanta
Subject No: 11121301 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-22-2020 13:13:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
…[truncated]