Document text
Page 1 of 161
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922339
Page 2 of 161
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/23/2020
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922340
Page 3 of 161
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Demography
1.Subject ID [10901536]
2.Birth Date: /1965
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:
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922341
Page 4 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/23/2020
2.Erroneous Visit
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922342
Page 5 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922343
Page 6 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/23/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922344
Page 7 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Ciprofloxacin allergy]
Start Date: UNK/UNK/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Levaquin allergy]
Start Date: UNK/UNK/2005
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/1967
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922345
Page 8 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Low serum iron]
Start Date: Jul/UNK/2020
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Nephrolithiasis]
Start Date: UNK/UNK/2005
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[vasectomy]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Low Vitamin D]
Start Date: UNK/UNK/2012
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Low Testosterone]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922346
Page 9 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/1985
Ongoing: YES
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922347
Page 10 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922348
Page 11 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Oct/23/2020
2.Weight: [95.6]
3.Unit: kg
4.Height: [173.2]
5.Unit: cm
6.Body Mass Index: [31.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922349
Page 12 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/23/2020
2.Randomization Number: [112156]
3.Randomization Group: [ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922350
Page 13 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/23/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCB9G]
5.bSample ID [BS7JP2]
5.cSample ID [BS7JP3]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922351
Page 14 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/23/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCB8Y]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922352
Page 15 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/23/2020 10:34
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922353
Page 16 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922354
Page 17 of 161
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/13/2020
2.Erroneous Visit
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922355
Page 18 of 161
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Nov/13/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922356
Page 19 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/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 [BRCBL1]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922357
Page 20 of 161
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/13/2020 13:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922358
Page 21 of 161
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922359
Page 22 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/18/2020
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 [BRCY4H]
5.bSample ID [BSHBN1]
5.cSample ID [BSHBNW]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922360
Page 23 of 161
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922361
Page 24 of 161
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922362
Page 25 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922363
Page 26 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922364
Page 27 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922365
Page 28 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922366
Page 29 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922367
Page 30 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: [ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922368
Page 31 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922369
Page 32 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922370
Page 33 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922371
Page 34 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922372
Page 35 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922373
Page 36 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922374
Page 37 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922375
Page 38 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922376
Page 39 of 161
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#CategoryAE Identif
ierAdverse Ev
entStart DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EV
ENT 1 Fever Oct/24/2020 UNK:
UNK NO
End Date Time:
Oct/25/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Myalgia Oct/24/2020 UNK:
UNK NO
End Date Time:
Oct/25/2020 UNK:UNK
Repeating
Pages
3.ADVERSE EV
ENT 3 Myalgia Nov/14/2020 UNK:
UNK NO
End Date Time:
Nov/16/2020 UNK:UNK
Repeating
Pages
4.ADVERSE EV
ENT 4 pyelonephrit
is Feb/11/2021 UNK:
UNK NO
End Date Time:
Feb/12/2021 UNK:UNK
Repeating
Pages
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922377
Page 40 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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)[Fever]
4.Start Date Time: Oct/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/25/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922378
Page 41 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
11.Was a Concomitant Medication
given?YES
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[ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922379
Page 42 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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)[Myalgia]
4.Start Date Time: Oct/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/25/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922380
Page 43 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
11.Was a Concomitant Medication
given?YES
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[ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922381
Page 44 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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)[Myalgia]
4.Start Date Time: Nov/14/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/16/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922382
Page 45 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
11.Was a Concomitant Medication
given?YES
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[ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922383
Page 46 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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)[pyelonephritis]
4.Start Date Time: Feb/11/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/12/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922384
Page 47 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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:
[nephrolithiasis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
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[2021247763]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922385
Page 48 of 161
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922386
Page 49 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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[ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922387
Page 50 of 161
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922388
Page 51 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: //
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922389
Page 52 of 161
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922390
Page 53 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922391
Page 54 of 161
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922392
Page 55 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922393
Page 56 of 161
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922394
Page 57 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922395
Page 58 of 161
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922396
Page 59 of 161
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Unplanned Assessments
1.Assessments
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922397
Page 60 of 161
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922398
Page 61 of 161
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922399
Page 62 of 161
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922400
Page 63 of 161
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922401
Page 64 of 161
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922402
Page 65 of 161
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922403
Page 66 of 161
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/5/2021
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922404
Page 67 of 161
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/5/2021
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 [BTWT63]
5.bSample ID [BVV2WP]
5.cSample ID [BVV2WN]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922405
Page 68 of 161
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/5/2021
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 [BTWT59]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922406
Page 69 of 161
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/18/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922407
Page 70 of 161
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit:
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922408
Page 71 of 161
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922409
Page 72 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922410
Page 73 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922411
Page 74 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922412
Page 75 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/8/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922413
Page 76 of 161
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922414
Page 77 of 161
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922415
Page 78 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/18/2020
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922416
Page 79 of 161
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922417
Page 80 of 161
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Lisa Cohen Approved Mar-12-2021 09:06:28 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LisaCohen, 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.
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922418
Page 81 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormOct-23-2020 13:18:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922419
Page 82 of 161
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Lisa Cohen Approved Mar-12-2021 09:06:28 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LisaCohen, 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 Mar-11-2021 15:46:13 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Lisa Cohen Approved Mar-09-2021 07:57:31 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LisaCohen, 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 Mar-08-2021 17:12:59 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922420
Page 83 of 161
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Lisa Cohen Approved Mar-08-2021 13:00:31 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LisaCohen, 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 Mar-08-2021 12:57:20 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Lisa Cohen Approved Mar-08-2021 09:49:55 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LisaCohen, 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 Mar-08-2021 08:59:33 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Lisa Cohen Approved Mar-08-2021 08:37:39 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922421
Page 84 of 161
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
By my dated signature below, I, LisaCohen, 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 Mar-05-2021 17:01:54 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Dec-22-2020 10:41:08 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-22-2020 10:04:50 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Dec-21-2020 09:52:56 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922422
Page 85 of 161
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
By my dated signature below, I, MatthewHong, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-18-2020 17:02:56 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Dec-18-2020 16:18:20 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-18-2020 15:26:24 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Hong Approved Dec-14-2020 12:51:22 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0922423
Page 86 of 161
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
By my dated signature below, I, MatthewHong, 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.
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922424
Page 87 of 161
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-23-2020 13:17:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-23-2020 13:17:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922425
Page 88 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-23-2020 13:17:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Oct/23/2020Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922426
Page 89 of 161
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-23-2020 13:17:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10901536Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-23-2020 13:17:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1965Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-23-2020 13:18:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-23-2020 13:18:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-23-2020 13:18:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922427
Page 90 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-23-2020 13:18:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/23/2020Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922428
Page 91 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-23-2020 13:19:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-23-2020 13:19:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-23-2020 13:19:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922429
Page 92 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Oct-23-2020 13:21:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:Ciprofloxacin
allergy
Start Date: UNK/UNK/20
05
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:21:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:21:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Ciprofloxacin allergyInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-23-2020 13:21:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-23-2020 13:21:06
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922430
Page 93 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada)
1.b
Date Location User Value Reason
Oct-23-2020 13:22:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Levaquin all
ergy
Start Date: UNK/UNK/2
005
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:22:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:22:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Levaquin allergyInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-23-2020 13:22:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-23-2020 13:22:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922431
Page 94 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.c
Date Location User Value Reason
Oct-23-2020 13:22:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:Asthma
Start Date: UNK/UNK/1
967
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:22:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:22:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AsthmaInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-23-2020 13:22:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1967Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-23-2020 13:22:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922432
Page 95 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-23-2020 13:23:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:4
Medical History
Term:Hypertensio
n
Start Date: UNK/UNK/
1990
Ongoing: YESTranscription Error
Oct-23-2020 13:22:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:Hypertensio
n
Start Date: UNK/UNK/
1967
Ongoing: YESInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922433
Page 96 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.d Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:22:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:22:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-23-2020 13:23:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Transcription Error
Oct-23-2020 13:22:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1967Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-23-2020 13:22:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-23-2020 13:24:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:Low serum i
ron
Start Date: Jul/UNK/20
20Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922434
Page 97 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:24:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:24:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Low serum ironInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-23-2020 13:24:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/UNK/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-23-2020 13:24:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-23-2020 13:24:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:Nephrolithia
sis
Start Date: UNK/UNK/2
005
Ongoing: YESInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922435
Page 98 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.f Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:24:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:24:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NephrolithiasisInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-23-2020 13:24:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-23-2020 13:24:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Oct-23-2020 13:25:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:7
Medical History
Term:vasectomy
Start Date: UNK/UNK/20
01Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922436
Page 99 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Ongoing: NO
End Date:
UNK/UNK/
2001
1.g Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:25:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:25:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
vasectomyInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-23-2020 13:25:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-23-2020 13:25:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2001Initial Entry
1.h
Date Location User Value Reason
Oct-23-2020 13:27:49
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe 8Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922437
Page 100 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada) r:
Medical History
Term:Low Vitamin
D
Start Date: UNK/UNK/2
012
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Low Vitamin DInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-23-2020 13:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-23-2020 13:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Oct-23-2020 13:28:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922438
Page 101 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Medical History
Term:Low Testoste
rone
Start Date: UNK/UNK/2
015
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:28:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:28:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Low TestosteroneInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-23-2020 13:28:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-23-2020 13:28:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Oct-23-2020 13:28:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:10Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922439
Page 102 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Medical History
Term:Depression
Start Date: UNK/UNK/1
985
Ongoing: YES
1.j Line/MH Number:
Date Location User Value Reason
Oct-23-2020 13:28:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:28:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DepressionInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922440
Page 103 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.j Start Date:
Date Location User Value Reason
Oct-23-2020 13:28:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-23-2020 13:28:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922441
Page 104 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-23-2020 13:29:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to b
e HIV POSITIVEInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922442
Page 105 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Oct-23-2020 13:29:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/23/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-23-2020 13:29:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
95.6Initial Entry
3. Unit:
Date Location User Value Reason
Oct-23-2020 13:29:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-23-2020 13:29:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
173.2Initial Entry
5. Unit:
Date Location User Value Reason
Oct-23-2020 13:29:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922443
Page 106 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-23-2020 13:29:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
31.9Initial Entry
7.a
Date Location User Value Reason
Oct-23-2020 13:29:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 98.1
Temperature Uni
t:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-23-2020 13:29:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-23-2020 13:29:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-23-2020 13:29:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922444
Page 107 of 161
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-23-2020 13:29:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922445
Page 108 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-23-2020 13:29:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/23/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-23-2020 13:29:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
112156Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922446
Page 109 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-23-2020 16:52:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-23-2020 16:52:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-23-2020 16:52:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-23-2020 16:52:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-23-2020 16:52:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/23/2020Initial Entry
5.a
Date Location User Value Reason
Oct-23-2020 16:52:11 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0922447
Page 110 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern
Time (US & Canada)Sample ID: BRCB9G
5.a Sample ID
Date Location User Value Reason
Oct-23-2020 16:52:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRCB9GInitial Entry
5.b
Date Location User Value Reason
Oct-23-2020 16:52:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS7JP2Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-23-2020 16:52:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS7JP2Initial Entry
5.c
Date Location User Value Reason
Oct-23-2020 16:52:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS7JP3Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-23-2020 16:52:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS7JP3Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0922448
Page 111 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-23-2020 16:14:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-23-2020 16:14:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-23-2020 16:14:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-23-2020 16:14:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-23-2020 16:14:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/23/2020Initial Entry
5.a
Date Location User Value Reason
Oct-23-2020 16:14:18 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0922449
Page 112 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern
Time (US & Canada)Sample ID: BRCB8Y
5.a Sample ID
Date Location User Value Reason
Oct-23-2020 16:14:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRCB8YInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0922450
Page 113 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-23-2020 13:30:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-23-2020 13:30:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-23-2020 13:30:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-23-2020 13:30:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/23/2020 10:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-23-2020 13:30:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922451
Page 114 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-23-2020 13:30:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-23-2020 13:30:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-23-2020 13:30:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-23-2020 13:30:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922452
Page 115 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-23-2020 13:31:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922453
Page 116 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-13-2020 15:14:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/13/2020Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922454
Page 117 of 161
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Nov-13-2020 15:14:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/13/2020Initial Entry
2.a
Date Location User Value Reason
Nov-13-2020 15:14:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 98.7
Temperature Uni
t:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-13-2020 15:14:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-13-2020 15:14:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.7Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-13-2020 15:14:42
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922455
Page 118 of 161
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada)
2.a Temperature Location:
Date Location User Value Reason
Nov-13-2020 15:14:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922456
Page 119 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-13-2020 16:17:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020 16:17:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020 16:17:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-13-2020 16:17:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-13-2020 16:17:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/13/2020Initial Entry
5.a
Date Location User Value Reason
Nov-13-2020 16:17:49 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922457
Page 120 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern
Time (US & Canada)Sample ID: BRCBL1
5.a Sample ID
Date Location User Value Reason
Nov-13-2020 16:17:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRCBL1Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922458
Page 121 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-13-2020 15:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-13-2020 15:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-13-2020 15:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-13-2020 15:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/13/2020 13:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-13-2020 15:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922459
Page 122 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-13-2020 15:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-13-2020 15:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-13-2020 15:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-13-2020 15:15:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922460
Page 123 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-18-2020 15:26:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922461
Page 124 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-18-2020 17:02:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-18-2020 17:02:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-18-2020 17:03:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-18-2020 17:02:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-18-2020 17:02:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/18/2020Initial Entry
5.a
Date Location User Value Reason
Dec-18-2020 17:03:07 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922462
Page 125 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern
Time (US & Canada)Sample ID: BRCY4H
5.a Sample ID
Date Location User Value Reason
Dec-18-2020 17:03:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRCY4HInitial Entry
5.b
Date Location User Value Reason
Dec-18-2020 17:03:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSHBN1Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-18-2020 17:03:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSHBN1Initial Entry
5.c
Date Location User Value Reason
Dec-18-2020 17:03:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSHBNWInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-18-2020 17:03:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSHBNWInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922463
Page 126 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Oct-27-2020 13:16:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922464
Page 127 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Oct-27-2020 13:17:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922465
Page 128 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Dec-18-2020 15:27:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922466
Page 129 of 161
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Mar-08-2021 08:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0922467
Page 130 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Oct-27-2020 13:16:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-27-2020 13:16:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-27-2020 13:16:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FeverInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 13:16:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/24/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-27-2020 13:16:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/25/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922468
Page 131 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-27-2020 13:16:56
(UTC-05:00) Eastern
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 medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-27-2020 13:16:56
(UTC-05:00) Eastern
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-27-2020 13:16:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-27-2020 13:16:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-27-2020 13:16:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922469
Page 132 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-27-2020 13:16:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-27-2020 13:16:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-27-2020 13:16:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-27-2020 13:16:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922470
Page 133 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Oct-27-2020 13:17:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-27-2020 13:17:51
(UTC-05:00) Eastern
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
Dec-22-2020 13:51:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Patricia
BancheroQuery 1: Closed Response satisfies
query
Dec-22-2020 10:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Dec-22-2020 10:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MyalgiaChanged
Information
Dec-22-2020 00:48:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN: For
coding accuracy,
please consider
updating the
verbatim term to
myalgia, as
applicable.
Otherwise, please
clarify. Thank you.
Dec-21-2020 21:58:57
(UTC-05:00) EasternACV0PFEINFP6000 Patricia
BancheroQuery 1: Candidate GPDCLIN: For
coding accuracy,
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922471
Page 134 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada) please consider
updating the
verbatim term to
myalgia, as
applicable.
Otherwise, please
clarify. Thank you.
Oct-27-2020 13:17:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Body achesInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 13:17:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/24/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-27-2020 13:17:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/25/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-27-2020 13:17:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial 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).
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922472
Page 135 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-27-2020 13:17:51
(UTC-05:00) Eastern
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-27-2020 13:17:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-27-2020 13:17:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-27-2020 13:17:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-27-2020 13:17:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-27-2020 13:17:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922473
Page 136 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-27-2020 13:17:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-27-2020 13:17:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922474
Page 137 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Dec-18-2020 15:27:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-18-2020 15:27:22
(UTC-05:00) Eastern
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
Dec-22-2020 13:50:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Patricia
BancheroQuery 1: Closed Response satisfies
query
Dec-22-2020 10:05:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Dec-22-2020 10:05:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MyalgiaChanged
Information
Dec-21-2020 21:58:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Patricia
BancheroQuery 1: Opened GPDCLIN: For
coding accuracy,
please consider
updating the
verbatim term to
myalgia, as
applicable.
Otherwise, please
clarify. Thank you.
Dec-18-2020 15:27:22
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
BodyachesInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922475
Page 138 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada)
4. Start Date Time:
Date Location User Value Reason
Dec-18-2020 15:27:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/14/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-18-2020 15:27:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/16/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-18-2020 15:27:22
(UTC-05:00) Eastern
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 medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-18-2020 15:27:22
(UTC-05:00) Eastern
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
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922476
Page 139 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Dec-18-2020 15:27:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-18-2020 15:27:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-18-2020 15:27:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-18-2020 15:27:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-18-2020 15:27:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-18-2020 15:27:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922477
Page 140 of 161
***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, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Dec-18-2020 15:27:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922478
Page 141 of 161
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Mar-08-2021 08:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-08-2021 08:59:33
(UTC-05:00) Eastern
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
Mar-08-2021 08:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
pyelonephritisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-11-2021 22:40:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-11-2021 16:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered we will update
when we have
more information.
no medical records
yet from urologist.
Mar-11-2021 13:54:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - SAE is 1
day duration. In
Vaccine study,
SAE start date is
day event starts;
not day it meets
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0922479
Page 142 of 161
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
serious criteria ie
HOSP (item 11 in
vaccine SAE
instruct). Please
review start / stop
dates of entire
event duration, &
update in AE/SAE
as needed
Mar-08-2021 08:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/11/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-08-2021 08:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/12/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-08-2021 08:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial 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
Mar-09-2021 01:41:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0922480
Page 143 of 161
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Mar-08-2021 08:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
pyelonephritis:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Mar-08-2021 08:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th 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 disabil
ity/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important seri
ous event
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.
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0922481
Page 144 of 161
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Mar-08-2021 08:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-12-2021
09:58:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: ClosedResponse
satisfies query
Mar-11-2021
15:46:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1
: Answe
redNew
Information
Mar-11-2021
15:46:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tre
atment
(s), thi
s event
is due
to:
OTH
ER
If O
ther
, sp
ecifNew
Information
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0922482
Page 145 of 161
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
y:
ne
p
hr
ol
it
hi
as
is
Mar-11-2021
13:12:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Reissu
ed:Open
edform unfrozen,
please update
Mar-11-2021
10:41:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answe
redalready entered
in med hx ,
please unfreeze
AE, so we can
match the exact
wording
:Nephrolithiasis
Mar-11-2021
10:01:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1
: Opene
dPlease review
"If not related
to study
treatment
other" field, the
following text
was indicated
in the comment
field [kidney
infections].
Kindly confirm
this condition is
related to any
pre existing
event, if so
please review
and update the
Medical
History, else
clarify. "
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922483
Page 146 of 161
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Mar-08-2021
08:59:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tre
atment
(s), thi
s event
is due
to:
OTH
ER
If O
ther
, sp
ecif
y:
m
ed
h
x
of
re
cu
rr
en
t
ki
d
ne
y
in
fe
ct
io
nsInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922484
Page 147 of 161
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-08-2021 08:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-12-2021 11:15:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-12-2021 07:51:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered this is already on
the SAE report. I
have no further
information yet
Mar-11-2021 23:14:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Clinical - Thank
you; please submit
the to the report
that Pt reports
antibiotic use for
this SAE
Mar-11-2021 15:47:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered no medical records
yet available, pt
only stated
antibiotics- no
information what
kind so far
Mar-11-2021 13:53:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical -
medication for SAE
is YES; however,
SAE report does
not include any
medication given
for pyelonephritis.
Please submit a
SAE update with
SAE medication;
also all Con meds
receiving prior to
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0922485
Page 148 of 161
***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, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
SAE
Mar-08-2021 08:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-08-2021 08:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-08-2021 08:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-08-2021 08:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-09-2021 01:41:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021247763Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0922486
Page 149 of 161
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-09-2021 02:39:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-08-2021 12:59:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Mar-08-2021 08:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly review
and complete
‘Immunogenicity
and Nasal Swab
forms' at this visit.
Thank you.
Mar-05-2021 17:01:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/5/2021Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922487
Page 150 of 161
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Mar-05-2021 17:02:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Mar/5/2021Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922488
Page 151 of 161
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-08-2021 12:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-08-2021 12:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-08-2021 12:59:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-08-2021 12:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-08-2021 12:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/5/2021Initial Entry
5.a
Date Location User Value Reason
Mar-08-2021 12:59:07 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922489
Page 152 of 161
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern
Time (US & Canada)Sample ID: BTWT63
5.a Sample ID
Date Location User Value Reason
Mar-08-2021 12:59:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BTWT63Initial Entry
5.b
Date Location User Value Reason
Mar-08-2021 12:59:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BVV2WPInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-08-2021 12:59:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BVV2WPInitial Entry
5.c
Date Location User Value Reason
Mar-08-2021 12:59:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BVV2WNInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-08-2021 12:59:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BVV2WNInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922490
Page 153 of 161
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-08-2021 12:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-08-2021 12:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-08-2021 12:58:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-08-2021 12:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-08-2021 12:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/5/2021Initial Entry
5.a
Date Location User Value Reason
Mar-08-2021 12:58:20 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922491
Page 154 of 161
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern
Time (US & Canada)Sample ID: BTWT59
5.a Sample ID
Date Location User Value Reason
Mar-08-2021 12:58:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BTWT59Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922492
Page 155 of 161
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-18-2020 15:26:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-18-2020 15:26:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-18-2020 15:26:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922493
Page 156 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-09-2021 15:21:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-09-2021 10:58:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject wanted to be
unblinded on the day
of his
ASYMPTOMATIC
SURVEILLANCE
visit. So the dates are
same.
Mar-09-2021 02:00:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM Query: Visit
date of INFORMED
CONSENT -
ASYMPTOMATIC
SURVEILLANCE -
5/Mar/2021 and Visit
Date of ‘REVAX
CONTACT’
5/Mar/2021 are
duplicate. Please
verify and confirm
the dates and update
the database if
require, else clarify.
Mar-08-2021 17:12:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/5/2021Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922494
Page 157 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-08-2021 17:13:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-08-2021 17:13:08
(UTC-05:00) Eastern
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.
Mar-08-2021 17:13:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible and NOT confirme
d to have received only pla
cebo at Vaccination 1/2Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922495
Page 158 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-08-2021 17:13:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/8/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-08-2021 17:13:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0922496
Page 159 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-18-2020 15:26:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-23-2020 13:29:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-23-2020 13:19:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-09-2021 01:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Mar-08-2021 12:35:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per query
Mar-08-2021 05:43:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2021247763
pyelonephritis(onset date:
11Feb2021)was reported as
serious in Safety database
but missing in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Dec-18-2020 15:26:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/18/2020Initial Entry
Oct-23-2020 13:29:58
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/23/2020Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0922497
Page 160 of 161
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada)
Oct-23-2020 13:19:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/23/2020Initial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0922498
Page 161 of 161
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901536 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Casebook Signature
Date Location User Value Reason
Dec-14-2020 12:51:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Matthew
HongData Entry:
Click Here to EnableInitial Entry
090177e196ae3d83\Final\Final On: 01-Apr-2021 04:36 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0922499