Document text
Page 1 of 125
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843550
Page 2 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/10/2020
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843551
Page 3 of 125
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11621327]
2.Birth Date: /1960
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843552
Page 4 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843553
Page 5 of 125
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843554
Page 6 of 125
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843555
Page 7 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[traumatic brain injury]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[reading glasses]
Start Date: UNK/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[autoimmune thyroiditis] Comments
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843556
Page 8 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hip replacement]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[depression]
Start Date: UNK/UNK/2011
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[overweight/obese]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843557
Page 9 of 125
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
2.Weight: [100.4]
3.Unit: kg
4.Height: [175.5]
5.Unit: cm
6.Body Mass Index: [32.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843558
Page 10 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/10/2020
2.Randomization Number: [254533]
3.Randomization Group: [ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843559
Page 11 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
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 [BP8D0F]
5.bSample ID [BPLN8P]
5.cSample ID [BPLN8R]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843560
Page 12 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
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 [BP8D0D]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843561
Page 13 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/10/2020 12:09
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843562
Page 14 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843563
Page 15 of 125
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843564
Page 16 of 125
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843565
Page 17 of 125
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843566
Page 18 of 125
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843567
Page 19 of 125
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843568
Page 20 of 125
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843569
Page 21 of 125
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843570
Page 22 of 125
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843571
Page 23 of 125
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843572
Page 24 of 125
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843573
Page 25 of 125
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843574
Page 26 of 125
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843575
Page 27 of 125
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843576
Page 28 of 125
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843577
Page 29 of 125
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843578
Page 30 of 125
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843579
Page 31 of 125
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
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?
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843580
Page 32 of 125
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843581
Page 33 of 125
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843582
Page 34 of 125
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843583
Page 35 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843584
Page 36 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843585
Page 37 of 125
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Sep/13/2020
2.Phase of Disposition: VACCINATION
3.Status: DEATH
4.Specify Status: [Cause of Death Atherosclerotic Disease]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843586
Page 38 of 125
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death :Sep/13/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843587
Page 39 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843588
Page 40 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843589
Page 41 of 125
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Atherosclerotic
Disease Sep/13/2020 UN
K:UNK NO
End Date Time:
Sep/13/2020 UNK:U
NK
Repeating
Pages
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843590
Page 42 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[Atherosclerotic Disease]
4.Start Date Time: Sep/13/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/13/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843591
Page 43 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[underlying disease]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from
the study?YES
15.Serious Adverse Event
Number: For Pfizer Use Only[2020373811]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843592
Page 44 of 125
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categ
oryMedication
ErrorStart D
ateIs the medication error Sti
ll OngoingStudy Medication Erro
rs ActionForm Instanc
e
1. Repeating
Pages
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843593
Page 45 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843594
Page 46 of 125
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843595
Page 47 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: //
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843596
Page 48 of 125
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. Repeating
Pages
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843597
Page 49 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843598
Page 50 of 125
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryTreatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntStart Da
teForm Instance
1. Repeating
Pages
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843599
Page 51 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843600
Page 52 of 125
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843601
Page 53 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843602
Page 54 of 125
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843603
Page 55 of 125
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843604
Page 56 of 125
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843605
Page 57 of 125
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843606
Page 58 of 125
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843607
Page 59 of 125
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843608
Page 60 of 125
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843609
Page 61 of 125
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843610
Page 62 of 125
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843611
Page 63 of 125
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843612
Page 64 of 125
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843613
Page 65 of 125
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for
Unblinding:
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843614
Page 66 of 125
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843615
Page 67 of 125
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Death Details
1.Date of Collection /
Notification of Death:Sep/24/2020
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [atherosclerotic disease]
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843616
Page 68 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Sep/13/2020
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843617
Page 69 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843618
Page 70 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert
Riesenberg Approved Nov-13-2020 14:12:08 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertRiesenberg, 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.
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843619
Page 71 of 125
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-11-2020 09:03:58 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843620
Page 72 of 125
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1.cOct-13-2020 10:16:24 (UTC-05:00)
Eastern Time (US & Canada)This would not be updated in med hx as
site was not aware of this at screen and do
not have any other information as to start
date”
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843621
Page 73 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Robert
Riesenberg Approved Nov-13-2020 14:12:08 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertRiesenberg, 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-12-2020 10:30:43 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Riesenberg Approved Nov-10-2020 15:47:29 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertRiesenberg, 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.
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843622
Page 74 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
N/A Nov-07-2020 23:31:32 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert
Riesenberg Approved Nov-05-2020 18:43:21 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertRiesenberg, 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.
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0843623
Page 75 of 125
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-11-2020 09:03:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-11-2020 09:03:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843624
Page 76 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-11-2020 09:03:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obt
ained
Sep/10/2020Initial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843625
Page 77 of 125
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-02-2020
07:32:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed event added.
Sep-28-2020
06:29:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020373811
Atherosclerotic
Disease(onset
date:13Sep2020)was
reported as serious in
Safety database but
missing in AE CRF. Please
confirm and update CRF. If
safety update is required,
submit a follow-up SAE
Form.
Sep-11-2020
09:03:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11621327Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-11-2020 09:03:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1960Enrollment Entry
3. Sex:
Date Location User Value Reason
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0843626
Page 78 of 125
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-11-2020 09:03:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-11-2020 09:03:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATI
NO(A) OR OF SPANISH O
RIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-11-2020 09:03:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843627
Page 79 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-13-2020
03:21:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Closed closed as
subject died on
13Sep2020 as
per EOT.
Oct-12-2020
17:25:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Answered Visit 2 did not
occur. Subject
terminated
study.
Oct-05-2020
09:23:29
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Query 1: Opened DM: Details on
visit ‘V2VX2L’
are missing.
Kindly consider
to update or else
clarify. Thank
you.
Sep-11-2020
09:03:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/10/2020Initial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843628
Page 80 of 125
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-11-2020 09:04:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-11-2020 09:04:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-11-2020 09:04:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843629
Page 81 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Sep-14-2020
11:00:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:1
Medical His
tory Term:traumatic bra
in injury
Start Date: UNK/UNK/
2011
Ongoing: NO
End Date:
UNK/UN
K/2011New Information
Sep-11-2020
09:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:tbi
Start Date: UNK/UNK/
2011
Ongoing: NO
End Date:
UNK/U
NK/2011Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-11-2020 09:04:55
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843630
Page 82 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Sep-14-2020
11:56:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy has
been closed.
Sep-14-2020
11:00:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dNew
Information
Sep-14-2020
11:00:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
traum
atic br
ain inj
uryNew
Information
Sep-11-2020
23:38:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedClarify as
follows TBI .
Please spell out
the abbreviation
TBI as it has
multiple
meaning. Please
clarify if
reporting
TRAUMATIC
BRAIN
INJURY? Or
THROMBOTIC
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843631
Page 83 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
BRAIN
INFARCTION?
Or other? Please
clarify and edit
as such. Thank
You.
Sep-11-2020
09:04:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
tbiInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-11-2020 09:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-11-2020 09:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
1.b
Date Location User Value Reason
Sep-11-2020 09:05:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:reading gla
ssesInitial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843632
Page 84 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Start Date: UNK/UNK
/2017
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Sep-11-2020 09:05:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 09:05:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
reading glassesInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-11-2020 09:05:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-11-2020 09:05:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-11-2020 09:07:09 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843633
Page 85 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH Nu
mber:3
Medical Hist
ory Term:autoimmune
thyroiditis
Start Date: UNK/UNK/2
010
Ongoing: YES
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843634
Page 86 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.c Line/MH Number:
Date Location User Value Reason
Sep-11-2020 09:07:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-13-2020
13:27:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Giselle Castillo Query 1: Closed Response
satisfies query
Oct-13-2020
10:16:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered This would not be
updated in med
hx as site was not
aware of this at
screen and do not
have any other
information as to
start date”
Oct-13-2020
07:40:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Giselle Castillo Query 1: Reissued:Op
enedPer case
narrative, "The
cause of death
was disease
progression and
atherosclerotic
disease". Please
confirm/clarify
the subject had a
Medical history
of atherosclerotic
disease. If
correct, please
update General
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843635
Page 87 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Med History
form correctly.
Oct-12-2020
17:26:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Atherosclerotic
disease added as
AE.
Sep-30-2020
08:30:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Giselle Castillo Query 1: Opened In the case
narrative of SDB
probable cause of
death is recorded
as atherosclerotic
disease. However,
subject has no
med hx of
Atherosclerotic
disease on CRF.
If so, please
update/revise
accordingly.
Thank you.
Sep-11-2020
09:07:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
autoimmune thyroiditi
sInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-11-2020 09:07:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843636
Page 88 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-11-2020 09:07:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-11-2020 09:07:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Histo
ry Term:hip replacem
ent
Start Date: UNK/UNK/2
015
Ongoing: NO
End Date:
UNK/UN
K/2015Initial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843637
Page 89 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.d Line/MH Number:
Date Location User Value Reason
Sep-11-2020 09:07:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 09:07:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hip replacementInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-11-2020 09:07:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-11-2020 09:07:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.e
Date Location User Value Reason
Sep-11-2020 09:08:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5Initial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843638
Page 90 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Medical Histor
y Term:depression
Start Date: UNK/UNK
/2011
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Sep-11-2020 09:08:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 09:08:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
depressionInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-11-2020 09:08:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-11-2020 09:08:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843639
Page 91 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-11-2020 09:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:overweight
/obese
Start Date: UNK/UNK
/2010
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Sep-11-2020 09:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 09:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
overweight/obeseInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-11-2020 09:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-11-2020 09:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843640
Page 92 of 125
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-11-2020 09:09:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-11-2020 09:09:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
100.4Initial Entry
3. Unit:
Date Location User Value Reason
Sep-11-2020 09:09:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-11-2020 09:09:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
175.5Initial Entry
5. Unit:
Date Location User Value Reason
Sep-11-2020 09:09:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (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-2021-5683-0843641
Page 93 of 125
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
6. Body Mass Index:
Date Location User Value Reason
Sep-11-2020 09:09:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
32.6Initial Entry
7.a
Date Location User Value Reason
Sep-11-2020 09:09:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identif
ier::1
Temperature: 36.6
Temperature
Unit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-11-2020 09:09:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-11-2020 09:09:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843642
Page 94 of 125
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-11-2020 09:09:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-11-2020 09:09:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843643
Page 95 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-14-2020 11:03:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-14-2020 11:03:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
254533Initial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843644
Page 96 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020 09:09:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020 09:09:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-14-2020
11:04:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-11-2020
10:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-11-2020
09:09:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0843645
Page 97 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
review and
correct as
appropriate.
Sep-11-2020
09:09:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-14-2020
11:07:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8D0FTranscription
Error
Sep-14-2020
11:04:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8D0DInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-14-2020
11:07:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8D0FTranscription
Error
Sep-14-2020
11:04:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8D0DInitial Entry
5.b
Date Location User Value Reason
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (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-2021-5683-0843646
Page 98 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-14-2020 11:07:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLN8PInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-14-2020 11:07:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPLN8PInitial Entry
5.c
Date Location User Value Reason
Sep-14-2020 11:07:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLN8RInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-14-2020 11:07:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPLN8RInitial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843647
Page 99 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020 09:09:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020 09:09:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-14-2020
11:08:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-11-2020
10:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-11-2020
09:09:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0843648
Page 100 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
review and
correct as
appropriate.
Sep-11-2020
09:09:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-14-2020 11:08:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8D0DInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-14-2020 11:08:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8D0DInitial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843649
Page 101 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-11-2020 09:09:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-11-2020 09:09:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-11-2020 09:09:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-11-2020 09:09:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/10/2020 12:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-11-2020 09:09:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843650
Page 102 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
6. Body Side:
Date Location User Value Reason
Sep-11-2020 09:09:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-11-2020 09:09:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-11-2020 09:09:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-11-2020 09:09:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843651
Page 103 of 125
***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: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-11-2020 09:10:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY
E-DIARY NOT COLLECT
ED FOR THIS SUBJECTInitial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843652
Page 104 of 125
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-12-2020
17:24:42
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-12-2020 17:24:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-11-2020
19:39:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Nov-08-2020
08:46:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Clinical request
Nov-07-2020
23:32:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered Added "specify
status"
information per
data monitor
query.
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843653
Page 105 of 125
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Nov-07-2020
23:31:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Nov-07-2020
23:31:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Response to
"Status" is
DEATH but
"Specify Status"
is Provided.
Nov-06-2020
03:48:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: EOT
status = Death.
When "Death" is
selected from the
"Status" list,
provide the
reason on the
"Specify Status"
line. Avoid
abbreviations.
Nov-05-2020
19:48:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Candidate ClinQuery: EOT
status = Death.
When "Death" is
selected from the
"Status" list,
provide the
reason on the
"Specify Status"
line. Avoid
abbreviations.
Oct-12-2020
17:24:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DEATHInitial Entry
4. Specify Status:
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843654
Page 106 of 125
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Nov-07-2020
23:31:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Cause of Death Atheros
clerotic DiseaseInitial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843655
Page 107 of 125
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-12-2020
17:24:59
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-12-2020 17:24:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Oct-12-2020
17:24:59
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
DEATHInitial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843656
Page 108 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Oct-01-2020
09:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843657
Page 109 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Oct-01-2020 09:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-01-2020 09:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-01-2020
09:02:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Atherosclerotic DiseaseInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-01-2020
09:02:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sep/13/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843658
Page 110 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-01-2020
09:03:23
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/13/2020 UNK:U
NKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-01-2020
09:02:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
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).
Date Location User Value Reason
Nov-03-2020
18:06:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Closed Response
satisfies query
Nov-03-2020
14:24:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Transcription
Error
Nov-03-2020
14:24:36
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event aTranscription
Error
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843659
Page 111 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)ssociated with conge
nital anomaly or birt
h defect?
NO
Did this serious even
t result in death?
YES
Did this serious even
t require or prolong h
ospitalization?
NO
Did this serious even
t result in persistent o
r significant disabilit
y/incapacity?
NO
Is this serious event l
ife threatening?
NO
Other medically imp
ortant serious event
NO
Oct-29-2020
14:34:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Balaji Prabu R Query 3: Opened Only the
seriousness
criteria "Did this
serious event
result in death?"
is answered, all
other serious
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843660
Page 112 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
criterias are left
blank. Please
answer all
seriousness
criteria questions
with "Yes" or
"No" response.
Thank you.
Oct-05-2020
07:57:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Oct-01-2020
09:43:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-01-2020
09:31:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered updated
Oct-01-2020
09:02:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Is this adverse
event serious?' is
reported 'Yes', but
at least one
seriousness
criteria is
missing. Please
review and
update as
appropriate.
Oct-01-2020
09:02:52
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
Atherosclerotic
Disease:
Response to "Is
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843661
Page 113 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada) the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
Oct-01-2020
09:02:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Did this serious even
t result in death?
YESInitial Entry
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.
Date Location User Value Reason
Oct-01-2020
09:02:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-11-2020
20:51:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Nov-03-2020
14:32:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Athersclerosis not
reported as part
of subject's
medical history
during Visit 1.
Athersclerosis is
suspected cause
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843662
Page 114 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
of death, but
subject was not
aware of this
medical condition
and did not report
it to site staff.
Oct-27-2020
05:13:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery:
Subject has AE of
Atherosclerosis
disease resulting
in Death. Noted
this was related to
underlying
disease but no
medical history
entered to reflect
that underlying
condition.
Oct-26-2020
20:40:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Candidate ClinQuery:
Subject has AE of
Atherosclerosis
disease resulting
in Death. Noted
this was related to
underlying
disease but no
medical history
entered to reflect
that underlying
condition.
Oct-01-2020
09:03:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this e
vent is due to:
OTHER
If Other, specify:New Information
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843663
Page 115 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
underlying disea
se
Oct-01-2020
09:02:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-13-2020
06:24:48
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Close
dResponse satisfies query
Nov-12-2020
10:30:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answ
eredTranscription Error
Nov-12-2020
10:30:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICA
BLETranscription Error
Nov-10-2020
07:44:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Reissu
ed:OpenedSAE RECON: Action
taken was recorded as NOT
APPLICABLE in Safety
database. If the correct
action taken drug
withdrawn, please submit a
follow up AEM form to
update action taken in
Safety database.
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843664
Page 116 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Nov-09-2020
09:03:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answ
eredChanged data per query
Nov-09-2020
06:55:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opene
dSAE
RECON:AER#2020373811
,action taken was reported
as DRUG WITHDRAWN
in AE CRF while NOT
APPLICABLE in Safety
database.Please confirm. If
safety update is required,
please submit a follow up
form
Nov-08-2020
07:58:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Close
dResponse satisfies query
Nov-08-2020
00:14:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answ
eredChanged Information
Nov-08-2020
00:14:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DRUG WITHD
RAWNChanged Information
Nov-06-2020
15:14:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Opene
dCLINQUERY: Since event
was fatal, please update
this entry to indicate that
treatment was discontinued
(withdrawn)
Oct-01-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843665
Page 117 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
09:02:52
(UTC-05:00)
Eastern Time
(US & Canada)NOT APPLICA
BLE
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-01-2020
09:02:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-01-2020
09:02:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-01-2020
09:02:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
FATALInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-23-2020
15:18:35
(UTC-05:00)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (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-2021-5683-0843666
Page 118 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)
Oct-23-2020
09:36:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Oct-19-2020
07:30:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened DM: 'Did the
adverse event
cause the subject
to be
discontinued
from the study?'
is Yes but neither
DISPOSITION -
TREATMENT
form nor
DISPOSITION -
FOLLOW-UP
has Status as
'ADVERSE
EVENT'. Please
review and
update as
appropriate.
Oct-12-2020
17:24:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Did the adverse
event cause the
subject to be
discontinued
from the study?'
is Yes but neither
DISPOSITION -
TREATMENT
form nor
DISPOSITION -
FOLLOW-UP
has Status as
''ADVERSE
EVENT''. Please
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0843667
Page 119 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
review and
update as
appropriate.
Oct-04-2020
07:43:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened DM: 'Did the
adverse event
cause the subject
to be
discontinued
from the study?'
is Yes but neither
DISPOSITION -
TREATMENT
form nor
DISPOSITION -
FOLLOW-UP
has Status as
'ADVERSE
EVENT'. Please
review and
update as
appropriate.
Oct-01-2020
09:02:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Did the adverse
event cause the
subject to be
discontinued
from the study?'
is Yes but neither
DISPOSITION -
TREATMENT
form nor
DISPOSITION -
FOLLOW-UP
has Status as
''ADVERSE
EVENT''. Please
review and
update as
appropriate.
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0843668
Page 120 of 125
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-01-2020
09:02:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-01-2020 09:43:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020373811Initial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0843669
Page 121 of 125
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Oct-18-2020
08:00:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Close
dResponse satisfies query
Oct-15-2020
13:45:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Answ
eredChanged data per query
Oct-12-2020
22:05:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Close
dDate of death matched in
Disposition treatment page
Oct-12-2020
21:59:42
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Erica Weaver Query 2: Close
dResponse satisfies query
Oct-12-2020
21:58:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Erica Weaver Query 3: Open
edPlease add at least the
PRIMARY CAUSE OF
DEATH below.
Oct-12-2020
20:48:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reiss
ued:OpenedSAE RECON 1: the date of
death was reported as
13Sep2020 in Safety
database while 24Sep2020
in AE CRF. Please confirm
correct date of death.If
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843670
Page 122 of 125
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
safety update is required,
please submit a follow-up
form.
Oct-12-2020
17:27:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answ
eredNotification of death was
24SEP2020, but death
occurred on 13SEP2020.
Please advise.
Oct-12-2020
17:24:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Open
edDate of Collection /
Notification of Death is
greater than the Date of
Completion/Discontinuation
/Death on the Disposition
form 13/Sep/2020. Please
review and update as
appropriate
Oct-12-2020
17:23:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answ
eredInitial Entry
Oct-12-2020
17:23:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/24/2020Initial Entry
Oct-02-2020
07:36:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Open
edSAE RECON:
AER#2020373811, the date
of death was reported as
13Sep2020 in Safety
database but missing in
CRF. Please confirm correct
date of death. If safety
update is required, please
submit a follow-up form.
2.a
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843671
Page 123 of 125
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Answered Queries, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Oct-15-2020 13:45:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cause of
Death Stat
us:PRIMARY CA
USE OF DEA
TH
Cause of
Death:atherosclerotic
diseaseInitial Entry
2.a Cause of Death Status:
Date Location User Value Reason
Mar-11-2021
16:29:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Feb-17-2021
11:54:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Medical
Monitor_ Pls
provide update
on the death
certificate. Would
you have further
information?
Thanks
Oct-15-2020
13:45:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CAUSE OF D
EATHInitial Entry
2.a Cause of Death:
Date Location User Value Reason
Oct-15-2020 13:45:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
atherosclerotic diseaseInitial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843672
Page 124 of 125
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-12-2020 17:24:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-12-2020 17:24:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Sep-14-2020 11:03:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZE
DInitial Entry
Sep-11-2020 09:04:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-12-2020 17:24:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/13/2020Initial Entry
Oct-12-2020 17:24:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/13/2020Initial Entry
Sep-14-2020 11:03:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
Sep-11-2020 09:04:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843673
Page 125 of 125
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1162 Site Name: (1162) Atlanta Center for Medical Research
Subject No: 11621327 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-05-2020
18:37:08
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f8f\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843674