Document text
Page 1 of 252
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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 version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920528
Page 2 of 252
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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
Aug/14/2020
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920529
Page 3 of 252
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Demography
1.Subject ID [10901187]
2.Birth Date: /1967
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:
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920530
Page 4 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/14/2020
2.Erroneous Visit
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920531
Page 5 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920532
Page 6 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920533
Page 7 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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:[Hernia Repair (L)]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Type I Diabetes]
Start Date: UNK/UNK/1982
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Depression]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920534
Page 8 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Aug/14/2020
2.Weight: [92.0]
3.Unit: kg
4.Height: [179.5]
5.Unit: cm
6.Body Mass Index: [28.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920535
Page 9 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/14/2020
2.Randomization Number: [50229]
3.Randomization Group: [ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920536
Page 10 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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:
Aug/14/2020
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 [BPLGHW]
5.bSample ID [BPLGHX]
5.cSample ID [BN5TSF]
5.dSample ID [BN5TSG]
5.eSample ID [BN5TSH]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920537
Page 11 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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:
Aug/14/2020
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 [BN5TRT]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920538
Page 12 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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: Aug/14/2020 13:04
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920539
Page 13 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920540
Page 14 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920541
Page 15 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920542
Page 16 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920543
Page 17 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920544
Page 18 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920545
Page 19 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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:
Sep/8/2020
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 [BP8F2Z]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920546
Page 20 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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: Sep/8/2020 11:49
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920547
Page 21 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920548
Page 22 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920549
Page 23 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920550
Page 24 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920551
Page 25 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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/12/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8FL5]
5.bSample ID [BS7JGC]
5.cSample ID [BS7JGD]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920552
Page 26 of 252
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920553
Page 27 of 252
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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/2/2021
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 [BTWT2N]
5.bSample ID [BVV2SV]
5.cSample ID [BVV2ST]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920554
Page 28 of 252
***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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920555
Page 29 of 252
***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: 10901187 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 [ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920556
Page 30 of 252
***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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920557
Page 31 of 252
***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: 10901187 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 [ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920558
Page 32 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: DATE OF VISIT - ILLNESS ONSET
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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920559
Page 33 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/9/2020
2.Date of First Symptom
Started:Nov/9/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/16/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920560
Page 34 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920561
Page 35 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920562
Page 36 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and
Description:Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings
/Details:Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920563
Page 37 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
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: 10901187 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_SELF
3.Sample Collected? YES
Date of Collection:
Nov/9/2020
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 [CV23215]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920564
Page 38 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: 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: 10901187 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? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[nasal swab completed]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920565
Page 39 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920566
Page 40 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920567
Page 41 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Treatment I
dentifierCon Non-Drug Treatme
nts Pre-specifiedTreatme
ntTreatme
ntStart Dat
eForm Instan
ce
1.Not Applicab
le Not Applicable Not Appli
cable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920568
Page 42 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: RESPIRATORY TREATMENT
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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment
Identifier?Not Applicable
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920569
Page 43 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?NO
3.Toxicity Grade: 1
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920570
Page 44 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1. Repeating
Pages
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920571
Page 45 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920572
Page 46 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1. Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920573
Page 47 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920574
Page 48 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
1. Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920575
Page 49 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920576
Page 50 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920577
Page 51 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920578
Page 52 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920579
Page 53 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920580
Page 54 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1. Repeating
Pages
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920581
Page 55 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920582
Page 56 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920583
Page 57 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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.Start Date: //
6.Ongoing?
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920584
Page 58 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
1. Repeating
Pages
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920585
Page 59 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920586
Page 60 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/07/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/7/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920587
Page 61 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/07/2020Form: 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: 10901187 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/7/2020
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 [BRCY1P]
5.bSample ID [BSHBJF]
5.cSample ID [BSHBJD]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920588
Page 62 of 252
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920589
Page 63 of 252
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Unplanned Assessments
1.Assessments
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920590
Page 64 of 252
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920591
Page 65 of 252
***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: 10901187 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: [ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920592
Page 66 of 252
***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: 10901187 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:
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920593
Page 67 of 252
***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: 10901187 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 [ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920594
Page 68 of 252
***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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#CategoryAE Ide
ntifierAdverse Ev
entStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Bell's Palsy r
ight face Sep/10/2020
UNK:UNK NO
End Date Time:
Sep/12/2020 UNK
:UNK
Repeating
Pages
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920595
Page 69 of 252
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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)[Bell's Palsy right face]
4.Start Date Time: Sep/10/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/12/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920596
Page 70 of 252
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920597
Page 71 of 252
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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[ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920598
Page 72 of 252
***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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920599
Page 73 of 252
***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: 10901187 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[ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920600
Page 74 of 252
***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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920601
Page 75 of 252
***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: 10901187 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: //
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920602
Page 76 of 252
***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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920603
Page 77 of 252
***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: 10901187 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?
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920604
Page 78 of 252
***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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920605
Page 79 of 252
***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: 10901187 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?
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920606
Page 80 of 252
***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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920607
Page 81 of 252
***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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920608
Page 82 of 252
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920609
Page 83 of 252
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10901187 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:
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920610
Page 84 of 252
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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?
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920611
Page 85 of 252
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920612
Page 86 of 252
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920613
Page 87 of 252
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920614
Page 88 of 252
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920615
Page 89 of 252
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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 [ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920616
Page 90 of 252
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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 [ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920617
Page 91 of 252
***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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920618
Page 92 of 252
***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: 10901187 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
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920619
Page 93 of 252
***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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/3/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920620
Page 94 of 252
***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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920621
Page 95 of 252
***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: 10901187 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: [ ]
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920622
Page 96 of 252
***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: 10901187 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 Oct/12/2020
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920623
Page 97 of 252
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10901187 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
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920624
Page 98 of 252
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10901187 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
Matthew
Hong Approved Mar-03-2021 13:26:59 (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.
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920625
Page 99 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormAug-17-2020 17:39:52 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920626
Page 100 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormNov-10-2020 07:59:44
(UTC-05:00) Eastern Time (US &
Canada)Not Done
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920627
Page 101 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Nov-10-2020 07:59:44 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920628
Page 102 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Nov-10-2020 07:59:44 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920629
Page 103 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Nov-10-2020 07:59:44 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920630
Page 104 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Nov-10-2020 07:59:44 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920631
Page 105 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5Nov-10-2020 07:59:44 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920632
Page 106 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6Nov-10-2020 07:59:44 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920633
Page 107 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
7Nov-10-2020 07:59:44 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920634
Page 108 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
8Nov-10-2020 07:59:44 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920635
Page 109 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
9Nov-10-2020 07:59:44 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920636
Page 110 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormNov-10-2020 08:02:51
(UTC-05:00) Eastern Time (US &
Canada)Not Applicable
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920637
Page 111 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Nov-10-2020 08:02:51 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920638
Page 112 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Nov-10-2020 08:02:51 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920639
Page 113 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Nov-10-2020 08:02:51 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920640
Page 114 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Nov-10-2020 08:02:51 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920641
Page 115 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5Nov-10-2020 08:02:51 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920642
Page 116 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6Nov-10-2020 08:02:51 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920643
Page 117 of 252
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10901187 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
Matthew
Hong Approved Mar-03-2021 13:26:59 (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 Mar-02-2021 16:39:12 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Hong Approved Feb-04-2021 14:26:06 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920644
Page 118 of 252
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10901187 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 Feb-04-2021 14:17:14 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Hong Approved Dec-07-2020 16:28:09 (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.
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920645
Page 119 of 252
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
N/A Dec-07-2020 16:27:06 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Hong Approved Dec-07-2020 16:26:11 (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-07-2020 15:56:44 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Hong Approved Dec-07-2020 15:05:40 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920646
Page 120 of 252
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10901187 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-07-2020 13:37:09 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Hong Approved Dec-04-2020 16:36:20 (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.
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920647
Page 121 of 252
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
N/A Dec-04-2020 15:24:45 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Hong Approved Nov-10-2020 09:42:25 (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 Nov-10-2020 07:58:12 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Wayne
Harper Approved Oct-20-2020 13:03:19 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920648
Page 122 of 252
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Affidavit:
By my dated signature below, I, WayneHarper, 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.
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920649
Page 123 of 252
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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
Aug-17-2020
17:38:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-17-2020
17:38:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920650
Page 124 of 252
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-17-2020
17:39:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/14/2020Initial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920651
Page 125 of 252
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-17-2020
17:38:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10901187Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-17-2020
17:38:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1967Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-17-2020
17:39:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920652
Page 126 of 252
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-17-2020
17:39:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-17-2020
17:39:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920653
Page 127 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-17-2020
17:39:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920654
Page 128 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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
Aug-17-2020
17:40:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-17-2020
17:40:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-17-2020
17:40:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920655
Page 129 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Aug-17-2020
17:41:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Hernia Re
pair (L)
Start Date
:UNK/UN
K/2009
Ongoing: NO
End Date
:
UNK/U
NK/200
9Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-17-2020
17:41:10
(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:
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920656
Page 130 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Aug-17-2020
17:41:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Hernia Repair (L)Initial Entry
1.a Start Date:
Date Location User Value Reason
Aug-17-2020
17:41:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-17-2020
17:41:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.b
Date Location User Value Reason
Aug-17-2020
17:41:53
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2Initial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920657
Page 131 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada) Medical His
tory Term:Type I D
iabetes
Start Date: UNK/U
NK/198
2
Ongoing: YES
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920658
Page 132 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.b Line/MH Number:
Date Location User Value Reason
Aug-17-2020
17:41:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020
17:41:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type I DiabetesInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-17-2020
17:41:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1982Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-17-2020
17:41:53ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920659
Page 133 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)
1.c
Date Location User Value Reason
Aug-17-2020
17:42:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:Depressio
n
Start Date
:UNK/UN
K/2017
Ongoing: NO
End Date
:
UNK/U
NK/201
8Initial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920660
Page 134 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.c Line/MH Number:
Date Location User Value Reason
Aug-17-2020
17:42:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020
17:42:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DepressionInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-17-2020
17:42:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-17-2020
17:42:34ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920661
Page 135 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/2018
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920662
Page 136 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Aug-17-2020
17:43:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-17-2020
17:43:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
92.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-17-2020
17:43:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920663
Page 137 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-17-2020
17:43:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
179.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-17-2020
17:43:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-17-2020
17:43:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28.6Initial Entry
7.a
Date Location User Value Reason
Aug-17-2020
17:43:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.4Initial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920664
Page 138 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-17-2020
17:43:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-17-2020
17:43:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-17-2020
17:43:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920665
Page 139 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
7.a Temperature Location:
Date Location User Value Reason
Aug-17-2020
17:43:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920666
Page 140 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-17-2020
17:43:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-17-2020
17:43:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
50229Initial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920667
Page 141 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-17-2020
17:44:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020
17:44:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-18-2020
11:47:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-18-2020
04:02:09
(UTC-05:00)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920668
Page 142 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-17-2020
17:44:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-17-2020
17:44:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-18-2020
11:47:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPLGH
WInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920669
Page 143 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-18-2020
11:47:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPLGHWInitial Entry
5.b
Date Location User Value Reason
Aug-18-2020
11:47:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPLGH
XInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-18-2020
11:47:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPLGHXInitial Entry
5.c
Date Location User Value Reason
Aug-18-2020
11:47:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BN5TS
FInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920670
Page 144 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.c Sample ID
Date Location User Value Reason
Aug-18-2020
11:47:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN5TSFInitial Entry
5.d
Date Location User Value Reason
Aug-18-2020
11:48:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BN5TS
GInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-18-2020
11:48:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN5TSGInitial Entry
5.e
Date Location User Value Reason
Aug-18-2020
11:48:15ACV0PFEINFP6000 Data Entry:
Sample I BN5TSInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920671
Page 145 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)D: H
5.e Sample ID
Date Location User Value Reason
Aug-18-2020
11:48:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN5TSHInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920672
Page 146 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-17-2020
17:44:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020
17:44:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-18-2020
11:47:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-18-2020
04:02:09
(UTC-05:00)ACV0PFEINFP6000 Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920673
Page 147 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-17-2020
17:44:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-17-2020
17:44:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-18-2020
11:47:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BN5TR
TInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920674
Page 148 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-18-2020
11:47:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN5TRTInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920675
Page 149 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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
Aug-17-2020
17:44:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-17-2020
17:44:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-17-2020
17:44:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920676
Page 150 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Aug-17-2020
17:44:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020 13:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-17-2020
17:44:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-17-2020
17:44:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-17-2020
17:44:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920677
Page 151 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-17-2020
17:44:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-17-2020
17:44:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920678
Page 152 of 252
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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
Aug-17-2020
17:44:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGEN
ICITY E-DIARY CO
LLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920679
Page 153 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-11-2020
03:43:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Sep-10-2020
12:09:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answere
dPD will be
recorded
Sep-10-2020
04:15:45
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened PDQ: Date of
visit at this
visit is out of
window (2
day) from
Date of visit
(14/Aug/2020)
at V1D1VX1L
visit. Please
reconcile and
update
accordingly,
else confirm
date is correct
as is.
Sep-09-2020
16:35:46ACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920680
Page 154 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time
(US & Canada)
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920681
Page 155 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or
systemic sympt
oms present on
the last day the
Subject Diary
was completed
?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920682
Page 156 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:N
OInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920683
Page 157 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.b Symptom:
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
A
D
A
C
HEInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920684
Page 158 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Were fever or
systemic symp
toms present
on the last da
y the Subject
Diary was co
mpleted?:N
O
2.c Symptom:
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-09-2020
16:36:30ACV0PFEINFP6000 Data Entry:
Symptom:: CInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920685
Page 159 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)HI
L
L
S
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:N
O
2.d Symptom:
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920686
Page 160 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or
systemic sym
ptoms present
on the last da
y the Subject
Diary was co
mpleted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920687
Page 161 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.f
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
A
RR
HE
A
Were fever or
systemic symp
toms present o
n the last day
the Subject Di
ary was compl
eted?:N
OInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920688
Page 162 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.f Symptom:
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE
PAINInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920689
Page 163 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Were fever
or systemic
symptoms
present on
the last day
the Subject
Diary was
completed?
:NO
2.g Symptom:
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSE
NED MUSCLE PAI
NInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920690
Page 164 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR
WOR
SEN
ED J
OINT
PAIN
Were fever
or systemic
symptoms
present on t
he last day
the Subject
Diary was c
ompleted?:NOInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920691
Page 165 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.h Symptom:
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSE
NED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920692
Page 166 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::R
E
D
N
ES
S
Were injection
site reactions
present on the
last day the Su
bject Diary wa
s completed?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920693
Page 167 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injectio
n site reaction
s present on t
he last day th
e Subject Dia
ry was compl
eted?:NOInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920694
Page 168 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Sit
e Reaction::PAI
N A
T IN
JEC
TIO
N SI
TEInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920695
Page 169 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Were injecti
on site reacti
ons present
on the last d
ay the Subje
ct Diary was
completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTI
ON SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-09-2020
16:36:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920696
Page 170 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Sep-09-2020
16:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
2.a
Date Location User Value Reason
Sep-09-2020
16:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Id
entifier::1
Temperat
ure:98.2
Temperat
ure Unit:F
Temperat
ure Locati
on::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-09-2020
16:36:49
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920697
Page 171 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-09-2020
16:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-09-2020
16:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-09-2020
16:36:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920698
Page 172 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020
16:37:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020
16:37:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-09-2020
16:37:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-09-2020
16:37:08
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920699
Page 173 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-09-2020
16:37:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-09-2020
16:37:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP8F2
ZInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-09-2020
16:37:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP8F2ZInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920700
Page 174 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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
Sep-09-2020
16:38:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-09-2020
16:38:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-09-2020
16:38:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920701
Page 175 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-09-2020
16:38:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/8/2020 11:49Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-09-2020
16:38:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-09-2020
16:38:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-09-2020
16:38:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920702
Page 176 of 252
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-09-2020
16:38:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-09-2020
16:38:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920703
Page 177 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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-12-2020
16:42:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920704
Page 178 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920705
Page 179 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920706
Page 180 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.b Symptom:
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920707
Page 181 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NO
2.c Symptom:
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Symptom:: C
HIInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920708
Page 182 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)L
LS
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
O
2.d Symptom:
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920709
Page 183 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920710
Page 184 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920711
Page 185 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.g
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
IN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NOInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920712
Page 186 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.g Symptom:
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAINInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920713
Page 187 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Were fever or
systemic sym
ptoms presen
t on the last d
ay the Subjec
t Diary was c
ompleted?:NO
2.h Symptom:
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-12-2020
16:43:48ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920714
Page 188 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)
4. Injection Site Body Side:
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection si
te reactions pres
ent on the last da
y the Subject Dia
ry was complete
d?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920715
Page 189 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:NOInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920716
Page 190 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-12-2020
16:44:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTIO
N SI
TEInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920717
Page 191 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NO
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTIO
N SI
TE
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:Initial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920718
Page 192 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-12-2020
16:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION
SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-12-2020
16:44:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0920719
Page 193 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020
16:26:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020
16:26:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020
16:26:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-12-2020
16:26:24
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920720
Page 194 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-12-2020
16:26:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Oct/12/2020Initial Entry
5.a
Date Location User Value Reason
Oct-12-2020
16:26:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP8FL
5Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-12-2020
16:26:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP8FL5Initial Entry
5.b
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920721
Page 195 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-12-2020
16:26:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BS7JG
CInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-12-2020
16:26:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BS7JGCInitial Entry
5.c
Date Location User Value Reason
Oct-12-2020
16:26:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BS7JG
DInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920722
Page 196 of 252
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.c Sample ID
Date Location User Value Reason
Oct-12-2020
16:26:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BS7JGDInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920723
Page 197 of 252
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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-02-2021
16:39:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/2/2021Initial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920724
Page 198 of 252
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-03-2021
11:31:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-03-2021
11:31:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-03-2021
11:31:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-03-2021
11:31:21
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920725
Page 199 of 252
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-03-2021
11:31:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Mar/2/2021Initial Entry
5.a
Date Location User Value Reason
Mar-03-2021
11:31:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BTWT2
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-03-2021
11:31:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BTWT2NInitial Entry
5.b
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920726
Page 200 of 252
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Mar-03-2021
11:31:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BVV2S
VInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-03-2021
11:31:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BVV2SVInitial Entry
5.c
Date Location User Value Reason
Mar-03-2021
11:32:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BVV2S
TInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920727
Page 201 of 252
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.c Sample ID
Date Location User Value Reason
Mar-03-2021
11:32:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BVV2STInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920728
Page 202 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 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-10-2020
08:00:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Nov-10-2020
07:58:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidat
eDate of Visit
is completed
but Date of
Assessment in
the Signs and
Symptoms
form is
missing.
Please review
and update as
appropriate.
Nov-10-2020
07:58:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
eDate of Visit
is completed
but Date of
Collection in
both Nasal
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920729
Page 203 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Swab Self and
Nasal Swab
are missing.
Please review
and update as
appropriate.
Nov-10-2020
07:58:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/9/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-10-2020
07:58:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920730
Page 204 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/9/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Nov/9/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Dec-07-2020
15:56:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Sym
ptom Resolved:
Nov/16/2020New
Information
Nov-10-2020
07:59:01ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920731
Page 205 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)
4.a
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEV
ER
Symptom P
resent:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920732
Page 206 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR I
NCREASE
D COUGH
Sympt
om Pr
esent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREA
SED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Nov-10-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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) (4), (b) (6)
FDA-CBER-2021-5683-0920733
Page 207 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)Sym
ptom
s:NEW OR I
NCREASE
D SHORTN
ESS OF BR
EATH
Sym
ptom
Pres
ent:NO
4.c Symptoms:
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREA
SED SHORTNESS
OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920734
Page 208 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHIL
LS
Symptom P
resent:NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symp
toms:NEW OR I
NCREASE
D MUSCL
E PAINInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920735
Page 209 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Symp
tom P
resent
:NO
4.e Symptoms:
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREA
SED MUSCLE PAI
NInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symp
toms:NEW LOS
S OF TAST
E OR SME
LLInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920736
Page 210 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Symp
tom P
resent
:NO
4.f Symptoms:
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TA
STE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symp
toms:NEW OR I
NCREASE
D SORE T
HROATInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920737
Page 211 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Symp
tom P
resent
:YES
4.g Symptoms:
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREA
SED SORE THRO
ATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:DIAR
RHEA
Symptom
Present:NOInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920738
Page 212 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.h Symptoms:
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:VOMI
TING
Symptom
Present:NOInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920739
Page 213 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.i Symptoms:
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-10-2020
07:59:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920740
Page 214 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-10-2020
07:59:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-10-2020
07:59:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-10-2020
07:59:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920741
Page 215 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-10-2020
07:59:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Nov-10-2020
07:59:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
Nov-10-2020
07:59:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7. Test Result:
Date Location User Value Reason
Nov-10-2020
07:59:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920742
Page 216 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
8. Comments/Findings/Details:
Date Location User Value Reason
Nov-10-2020
07:59:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Nov-10-2020
07:59:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920743
Page 217 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-10-2020
08:00:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-10-2020
08:00:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-10-2020
08:00:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-10-2020
08:00:04
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920744
Page 218 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-10-2020
08:00:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Nov/9/2020Initial Entry
5.a
Date Location User Value Reason
Nov-10-2020
08:00:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:CV232
15Changed
Information
Nov-10-2020
08:00:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:cv232
15Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-10-2020
08:00:42
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920745
Page 219 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US
& Canada)
Nov-10-2020
08:00:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CV23215Changed
Information
Nov-10-2020
08:00:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Barcode
contains lower
case letters
which is not
the correct
format. Please
review and
correct as
appropriate.
Nov-10-2020
08:00:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
cv23215Initial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920746
Page 220 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-10-2020
08:01:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-10-2020
08:01:41
(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-10-2020
08:01:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920747
Page 221 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Nov-10-2020
08:01:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
nasal swab complet
edInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920748
Page 222 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Nov-10-2020
08:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Pra
ctitioner:SPE
CIA
LIST
Occurrence
of Visits or
Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-10-2020
08:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-10-2020
08:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920749
Page 223 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.b
Date Location User Value Reason
Nov-10-2020
08:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of P
ractitione
r:EMER
GENC
Y ROO
M
Occurren
ce of Visit
s or Cont
acts:NOInitial Entry
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-10-2020
08:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY RO
OMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-10-2020
08:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920750
Page 224 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Nov-10-2020
08:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of
Practitio
ner:PRIMA
RY CAR
E PHYS
ICIAN
Occurre
nce of Vi
sits or C
ontacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-10-2020
08:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CARE
PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-10-2020
08:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920751
Page 225 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Nov-10-2020
08:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Type of Pr
actitioner:URG
ENT
CAR
E
Occurrenc
e of Visits o
r Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-10-2020
08:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-10-2020
08:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Nov-10-2020
08:02:33ACV0PFEINFP6000 Data Entry:
Type of TELEPInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920752
Page 226 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)Practitio
ner:HONE
CONSU
LTATIO
N
Occurre
nce of Vi
sits or C
ontacts:NO
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Nov-10-2020
08:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
TELEPHONE CON
SULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-10-2020
08:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Nov-10-2020
08:02:33ACV0PFEINFP6000 Data Entry:
Type of Pract OTInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920753
Page 227 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901187 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US
& Canada)itioner: HE
R
Occurrence o
f Visits or Co
ntacts:NO
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Nov-10-2020
08:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-10-2020
08:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Nov-10-2020
08:02:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d7c\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920754
Page 228 of 252
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Nov/09/2020Form: RESPIRATORY TREATMENT - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Researc
…[truncated]