Document text
Page 1 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815838
Page 2 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/25/2020
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815839
Page 3 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11781015]
2.Birth Date: /1953
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:
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815840
Page 4 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815841
Page 5 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815842
Page 6 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815843
Page 7 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[hypertension]
Start Date: UNK/UNK/2008
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[neck pain]
Start Date: UNK/UNK/2016
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[insomnia]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815844
Page 8 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[attention deficit disorder]
Start Date: UNK/UNK/2000
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[depression]
Start Date: UNK/UNK/1996
Ongoing: YES
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815845
Page 9 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
2.Weight: [172.0]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [25.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815846
Page 10 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/25/2020
2.Randomization Number: [239026]
3.Randomization Group: [ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815847
Page 11 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY84J]
5.bSample ID [BPY84K]
5.cSample ID [BPY84L]
5.dSample ID [BNWNXR]
5.eSample ID [BNWNXS]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815848
Page 12 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY84H]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815849
Page 13 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/25/2020 12:31
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
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815850
Page 14 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815851
Page 15 of 171
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815852
Page 16 of 171
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815853
Page 17 of 171
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY8MH]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815854
Page 18 of 171
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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/15/2020 13:55
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
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815855
Page 19 of 171
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815856
Page 20 of 171
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
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 [BPW3T9]
5.bSample ID [BNWPKR]
5.cSample ID [BNWPKS]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815857
Page 21 of 171
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/12/2021
2.Erroneous Visit
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815858
Page 22 of 171
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/12/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR7SNX]
5.bSample ID [BSGFS1]
5.cSample ID [BSGFS2]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815859
Page 23 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815860
Page 24 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815861
Page 25 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815862
Page 26 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815863
Page 27 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815864
Page 28 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: [ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815865
Page 29 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815866
Page 30 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815867
Page 31 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815868
Page 32 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815869
Page 33 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815870
Page 34 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815871
Page 35 of 171
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815872
Page 36 of 171
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Unplanned Assessments
1.Assessments
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815873
Page 37 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/13/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815874
Page 38 of 171
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815875
Page 39 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815876
Page 40 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815877
Page 41 of 171
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERS
E EVENT
1 injection site tender
ness Aug/25/202
0 19:00 NO
End Date Time:
Aug/26/2020 12
:00
Repeating
Pages
2.ADVERS
E EVENT
2 transient global amn
esia Oct/10/2020
UNK:UNK NO
End Date Time:
Oct/10/2020 UN
K:UNK
Repeating
Pages
3.ADVERS
E EVENT
3 Ascending aorta ect
asia Oct/10/2020
UNK:UNK YES Repeating
Pages
4.ADVERS
E EVENT
4 Diastolic dysfunctio
n of the left ventricl
e Oct/11/2020
UNK:UNK YES Repeating
Pages
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815878
Page 42 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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)[injection site tenderness]
4.Start Date Time: Aug/25/2020 19:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Aug/26/2020 12:00
6.Toxicity Grade: 1
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815879
Page 43 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815880
Page 44 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815881
Page 45 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[transient global amnesia]
4.Start Date Time: Oct/10/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/10/2020 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815882
Page 46 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815883
Page 47 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020397171]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815884
Page 48 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Ascending aorta ectasia]
4.Start Date Time: Oct/10/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815885
Page 49 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown, possibly hypertension]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815886
Page 50 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815887
Page 51 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Diastolic dysfunction of the left ventricle]
4.Start Date Time: Oct/11/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815888
Page 52 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown, possibly hypertension]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815889
Page 53 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815890
Page 54 of 171
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815891
Page 55 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815892
Page 56 of 171
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815893
Page 57 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: //
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815894
Page 58 of 171
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815895
Page 59 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815896
Page 60 of 171
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815897
Page 61 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815898
Page 62 of 171
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815899
Page 63 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815900
Page 64 of 171
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815901
Page 65 of 171
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815902
Page 66 of 171
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815903
Page 67 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815904
Page 68 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815905
Page 69 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815906
Page 70 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815907
Page 71 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815908
Page 72 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815909
Page 73 of 171
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815910
Page 74 of 171
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815911
Page 75 of 171
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/14/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815912
Page 76 of 171
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815913
Page 77 of 171
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815914
Page 78 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/13/2020
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815915
Page 79 of 171
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815916
Page 80 of 171
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815917
Page 81 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormAug-25-2020 15:24:55 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815918
Page 82 of 171
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Mar-12-2021 13:05:20 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephan
Sharp Approved Jan-20-2021 09:31:36 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephanSharp, 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 Jan-14-2021 15:58:51 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815919
Page 83 of 171
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Affidavit:
N/A
Stephan
Sharp Approved Oct-26-2020 10:13:23 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephanSharp, 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 Oct-22-2020 10:29:20 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephan
Sharp Approved Oct-20-2020 14:14:20 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815920
Page 84 of 171
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Affidavit:
By my dated signature below, I, StephanSharp, 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.
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815921
Page 85 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-25-2020
15:24:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-25-2020
15:24:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815922
Page 86 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-25-2020
15:24:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/25/2020Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815923
Page 87 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-25-2020
15:24:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11781015Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-25-2020
15:24:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1953Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-25-2020
15:24:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815924
Page 88 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Aug-25-2020
15:24:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-25-2020
15:24:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815925
Page 89 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-25-2020
15:24:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815926
Page 90 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-25-2020
15:25:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-25-2020
15:25:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-25-2020
15:25:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815927
Page 91 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.a
Date Location User Value Reason
Aug-25-2020
15:26:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:hyperten
sion
Start Date: UNK/U
NK/200
8
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-25-2020
15:26:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
15:26:14
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
hypertensionInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815928
Page 92 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Central Time (US
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-25-2020
15:26:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-25-2020
15:26:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-25-2020
15:26:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:neck pai
nInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815929
Page 93 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Start Date: UNK/U
NK/201
6
Ongoing: YES
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815930
Page 94 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.b Line/MH Number:
Date Location User Value Reason
Aug-25-2020
15:26:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
15:26:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
neck painInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-25-2020
15:26:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815931
Page 95 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Aug-25-2020
15:26:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-25-2020
15:27:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:insomnia
Start Date: UNK/U
NK/201
0
Ongoing: YESInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815932
Page 96 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.c Line/MH Number:
Date Location User Value Reason
Aug-25-2020
15:27:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
15:27:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
insomniaInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-25-2020
15:27:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815933
Page 97 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Aug-25-2020
15:27:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-25-2020
15:27:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical H
istory Ter
m:attention d
eficit disor
der
Start Date
:UNK/UN
K/2000
Ongoing: YESInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815934
Page 98 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.d Line/MH Number:
Date Location User Value Reason
Aug-25-2020
15:27:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
15:27:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
attention deficit disor
derInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-25-2020
15:27:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.d Ongoing:
Date Location User Value Reason
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815935
Page 99 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Aug-25-2020
15:27:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-25-2020
15:27:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:depressi
on
Start Date: UNK/U
NK/199
6
Ongoing: YESInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815936
Page 100 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.e Line/MH Number:
Date Location User Value Reason
Aug-25-2020
15:27:47
(UTC-06:00)
Central 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
Aug-25-2020
15:27:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
depressionInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-25-2020
15:27:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1996Initial Entry
1.e Ongoing:
Date Location User Value Reason
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815937
Page 101 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Aug-25-2020
15:27:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815938
Page 102 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020
15:28:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000
)Data Entry:
Aug/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020
15:28:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
172.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020
15:28:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815939
Page 103 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Aug-25-2020
15:28:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
69.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-25-2020
15:28:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-25-2020
15:28:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25.4Initial Entry
7.a
Date Location User Value Reason
Aug-25-2020
15:28:12
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
Record Ide 1Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815940
Page 104 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Central Time (US
& Canada)ntifier::
Temperatu
re:97.2
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-25-2020
15:28:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-25-2020
15:28:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
97.2Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815941
Page 105 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Aug-25-2020
15:28:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-25-2020
15:28:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815942
Page 106 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-25-2020
15:28:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020
15:28:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
239026Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815943
Page 107 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020
16:02:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020
16:02:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-25-2020
16:03:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-25-2020
16:02:53ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815944
Page 108 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-06:00)
Central Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-25-2020
16:02:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020
16:03:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPY84
JInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-25-2020
16:03:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPY84JInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815945
Page 109 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.b
Date Location User Value Reason
Aug-25-2020
16:03:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPY84
KInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-25-2020
16:03:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPY84KInitial Entry
5.c
Date Location User Value Reason
Aug-25-2020
16:03:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPY84
LInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815946
Page 110 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.c Sample ID
Date Location User Value Reason
Aug-25-2020
16:03:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPY84LInitial Entry
5.d
Date Location User Value Reason
Aug-25-2020
16:03:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BNWN
XRInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-25-2020
16:03:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BNWNXRInitial Entry
5.e
Date Location User Value Reason
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815947
Page 111 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Aug-25-2020
16:03:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BNWN
XSInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-25-2020
16:03:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BNWNXSInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815948
Page 112 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-25-2020
16:04:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-25-2020
16:04:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-25-2020
16:04:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-25-2020
16:04:00ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815949
Page 113 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-06:00)
Central Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-25-2020
16:04:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020
16:04:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPY84
HInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-25-2020
16:04:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPY84HInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815950
Page 114 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-25-2020
15:28:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020
15:28:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-25-2020
15:28:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815951
Page 115 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Aug-25-2020
15:28:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020 12:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020
15:28:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-25-2020
15:28:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-25-2020
15:28:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815952
Page 116 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-25-2020
15:28:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-25-2020
15:28:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815953
Page 117 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-25-2020
15:29:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENI
CITY E-DIARY NO
T COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815954
Page 118 of 171
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-15-2020
13:55:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815955
Page 119 of 171
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Sep-15-2020
13:55:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-15-2020
13:55:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.3
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-15-2020
13:55:21
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815956
Page 120 of 171
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Central Time (US
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-15-2020
13:55:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-15-2020
13:55:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-15-2020
13:55:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815957
Page 121 of 171
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020
15:17:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020
15:17:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-15-2020
15:17:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-15-2020
15:17:05ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815958
Page 122 of 171
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-06:00)
Central Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-15-2020
15:17:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-15-2020
15:17:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPY8M
HInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-15-2020
15:17:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPY8MHInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815959
Page 123 of 171
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-15-2020
13:55:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-15-2020
13:55:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-15-2020
13:55:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815960
Page 124 of 171
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-15-2020
13:55:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020 13:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-15-2020
13:55:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-15-2020
13:55:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-15-2020
13:55:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815961
Page 125 of 171
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-15-2020
13:55:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-15-2020
13:55:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815962
Page 126 of 171
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020
11:35:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815963
Page 127 of 171
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020
14:49:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020
14:49:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020
14:49:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-13-2020
14:49:42ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815964
Page 128 of 171
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-06:00)
Central Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-13-2020
14:49:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020
14:49:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPW3T
9Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-13-2020
14:49:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPW3T9Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815965
Page 129 of 171
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.b
Date Location User Value Reason
Oct-13-2020
14:50:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BNWPK
RInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-13-2020
14:50:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BNWPKRInitial Entry
5.c
Date Location User Value Reason
Oct-13-2020
14:50:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BNWP
KSInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815966
Page 130 of 171
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.c Sample ID
Date Location User Value Reason
Oct-13-2020
14:50:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BNWPKSInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815967
Page 131 of 171
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021
13:31:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/12/2021Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815968
Page 132 of 171
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-12-2021
13:05:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-12-2021
13:05:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-12-2021
13:05:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-12-2021
13:05:20ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815969
Page 133 of 171
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-06:00)
Central Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-12-2021
13:05:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Mar/12/2021Initial Entry
5.a
Date Location User Value Reason
Mar-12-2021
13:05:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BR7SN
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-12-2021
13:05:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR7SNXInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815970
Page 134 of 171
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.b
Date Location User Value Reason
Mar-12-2021
13:05:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BSGFS
1Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-12-2021
13:05:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSGFS1Initial Entry
5.c
Date Location User Value Reason
Mar-12-2021
13:05:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BSGFS
2Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815971
Page 135 of 171
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.c Sample ID
Date Location User Value Reason
Mar-12-2021
13:05:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BSGFS2Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815972
Page 136 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-14-2020
11:35:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020
11:35:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-14-2020
11:35:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815973
Page 137 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Sep-15-2020
13:53:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815974
Page 138 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Oct-13-2020
09:18:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815975
Page 139 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Oct-22-2020
10:29:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815976
Page 140 of 171
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Oct-22-2020
10:31:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815977
Page 141 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Sep-15-2020
13:53:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-15-2020
13:53:42
(UTC-06:00)
Central 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
Sep-15-2020
13:53:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
injection site tendern
essInitial Entry
4. Start Date Time:
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815978
Page 142 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Sep-15-2020
13:53:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020 19:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-15-2020
13:54:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Aug/26/2020 12:
00Transcription
Error
Sep-15-2020
13:53:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-15-2020
13:53:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815979
Page 143 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
Sep-15-2020
13:53:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial 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
Sep-15-2020
13:53:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-15-2020
13:53:42
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815980
Page 144 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Central Time (US
& Canada)
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-15-2020
13:53:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-15-2020
13:53:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-15-2020
13:53:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815981
Page 145 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Sep-15-2020
13:54:32
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: C
losedClose Auto Query
Sep-15-2020
13:53:42
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
OpenedFor AE injection site
tenderness: Response to
"What was the outcome of
this adverse event?" is
RECOVERED/RESOLVED
but End Date/Time is
missing.
Sep-15-2020
13:53:42
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data Entr
y:
RECOVE
RED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-15-2020
13:53:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815982
Page 146 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Oct-13-2020
09:18:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-13-2020
09:18:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-23-2020
23:16:24
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Giselle Castillo Query 1: Closed Appreciate the
prompt
response.
Thank you.
Oct-23-2020 ACV0PFEINFP6000 Query 1: Answer Test was NOT
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815983
Page 147 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
10:00:00
(UTC-06:00)
Central Time
(US & Canada)ed performed.
Follow Up SAE
report has been
submitted.
Oct-22-2020
12:37:12
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Giselle Castillo Query 1: Reissue
d:OpenedIf test was NOT
performed or
NOT available,
please add this
information as
well so it is
reflected in the
SAE case
narrative.
Thank you.
Oct-21-2020
16:24:49
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answer
edNo report of
Covid testing
Oct-21-2020
10:36:44
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Giselle Castillo Query 1: Opened COVID testing
has not been
reported in the
SAE submitted
to safety. Please
submit a
follow-up SAE
form to provide
whether
COVID testing
was performed
during
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815984
Page 148 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
hospitalization
(yes/no) and if
yes, the results.
Thank you.
Oct-13-2020
09:18:16
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
transient global a
mnesiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-13-2020
09:18:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/10/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-13-2020
09:18:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/10/2020 UNK
:UNKInitial Entry
6. Toxicity Grade:
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815985
Page 149 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Oct-13-2020
09:18:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
3Initial 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
Oct-14-2020
05:14:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-13-2020
09:18:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
transient
global
amnesia:
Response to
"Is the
adverse event
serious?" is
'Yes' but
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815986
Page 150 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
"Serious
Adverse
Event
Number" is
blank.
Oct-13-2020
09:18:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event
associated with con
genital anomaly or
birth defect?
NO
Did this serious eve
nt result in death?
NO
Did this serious eve
nt require or prolon
g hospitalization?
YES
Did this serious eve
nt result in persiste
nt or significant dis
ability/incapacity?
NO
Is this serious eventInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815987
Page 151 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
life threatening?
NO
Other medically im
portant serious eve
nt
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-15-2020
06:11:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Oct-14-2020
07:27:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription
Error
Oct-14-2020
07:27:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOTranscription
Error
Oct-14-2020
01:09:14ACV0PFEINFP6000 Query 1: Opened DM: Response
to 'Is this AE
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815988
Page 152 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-06:00)
Central Time (US
& Canada)the result of
Med Error?' is
YES, however
no Medication
Error with
corresponding
AE is recorded
under
Medication
Error page.
Kindly review
and update as
appropriate,
else clarify.
Oct-13-2020
09:18:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-13-2020
09:18:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815989
Page 153 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-13-2020
09:18:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-13-2020
09:18:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-13-2020
09:18:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815990
Page 154 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Oct-13-2020
09:18:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-13-2020
09:18:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-14-2020
05:14:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2020397171Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0815991
Page 155 of 171
***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
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Oct-22-2020
10:29:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-22-2020
10:29:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-22-2020
10:29:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Ascending aorta ectas
iaInitial Entry
4. Start Date Time:
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815992
Page 156 of 171
***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
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Oct-22-2020
10:29:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/10/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-22-2020
10:29:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-22-2020
10:29:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial 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
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815993
Page 157 of 171
***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
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-22-2020
10:29:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial 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-22-2020
10:29:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-22-2020
10:29:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815994
Page 158 of 171
***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
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Unknown, possi
bly hypertensio
n
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-22-2020
10:29:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-22-2020
10:29:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-22-2020
10:29:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815995
Page 159 of 171
***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
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-22-2020
10:29:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/
NOT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-22-2020
10:29:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815996
Page 160 of 171
***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
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Oct-22-2020
10:31:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-22-2020
10:31:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-22-2020
10:31:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Diastolic dysfunction
of the left ventricleInitial Entry
4. Start Date Time:
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815997
Page 161 of 171
***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
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Oct-22-2020
10:31:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/11/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-22-2020
10:31:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-22-2020
10:31:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial 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
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815998
Page 162 of 171
***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
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Oct-22-2020
10:31:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial 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-22-2020
10:31:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-22-2020
10:31:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815999
Page 163 of 171
***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
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Unknown, possi
bly hypertensio
n
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-22-2020
10:31:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-22-2020
10:31:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-22-2020
10:31:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0816000
Page 164 of 171
***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
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-22-2020
10:31:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/
NOT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-22-2020
10:31:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0816001
Page 165 of 171
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-14-2021
15:58:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/14/2021Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0816002
Page 166 of 171
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-14-2021
15:59:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-14-2021
15:58:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Jan-14-2021
15:58:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Participant is willin
g to return for Vacc
ination 3
Participant is:
eligible and NO
T confirmed to h
ave received onlInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0816003
Page 167 of 171
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
y placebo at Vac
cination 1/2
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816004
Page 168 of 171
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-14-2021
15:59:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/14/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-14-2021
15:59:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0816005
Page 169 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-14-2020
11:35:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-25-2020
15:28:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-25-2020
15:25:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-14-2020
11:35:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/13/2020Initial Entry
Aug-25-2020 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816006
Page 170 of 171
***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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
15:28:33
(UTC-06:00)
Central Time (US
& Canada)(autocalc) Aug/25/2020
Aug-25-2020
15:25:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/25/2020Initial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
FDA-CBER-2021-5683-0816007
Page 171 of 171
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781015 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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1. Casebook Signature
Date Location User Value Reason
Oct-20-2020
14:14:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Stephan
SharpData Entry:
Click Here to EnableInitial Entry
090177e196ae3fb5\Final\Final On: 01-Apr-2021 05:21 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0816008