125742 S1 M5 CRF c4591001 1178 11781257

Document text

Page 1 of 227
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818399
Page 2 of 227
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/25/2020
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818400
Page 3 of 227
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11781257]
2.Birth Date: /1968
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818401
Page 4 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818402
Page 5 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818403
Page 6 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818404
Page 7 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818405
Page 8 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818406
Page 9 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
2.Weight: [144.0]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [24.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [96.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818407
Page 10 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/25/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818408
Page 11 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/25/2020
2.Randomization Number: [99014]
3.Randomization Group: [ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818409
Page 12 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW3JN]
5.bSample ID [BNWPFN]
5.cSample ID [BNWPFP]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818410
Page 13 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW3JM]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818411
Page 14 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/25/2020 09:53
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818412
Page 15 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818413
Page 16 of 227
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818414
Page 17 of 227
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Oct/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818415
Page 18 of 227
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/16/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818416
Page 19 of 227
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
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 [BPW3W4]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818417
Page 20 of 227
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/16/2020 08:31
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818418
Page 21 of 227
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/13/2020
2.Erroneous Visit
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818419
Page 22 of 227
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/13/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR7GR4]
5.bSample ID [BRVDK1]
5.cSample ID [BRVDK2]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818420
Page 23 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818421
Page 24 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/29/2021
2.Date of First Symptom Started: Jan/28/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/30/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818422
Page 25 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [congestion, nasal]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818423
Page 26 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jan/29/20
21 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818424
Page 27 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/29/2021 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: THERMOFISHER APPL BIO TAQPATH COVID-19 COMBO
KITComments
7.Test Result: POSITIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [ ] Comments
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818425
Page 28 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Jan/29/2021
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 [CV46946]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818426
Page 29 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Telehealth Visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818427
Page 30 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818428
Page 31 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Treatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818429
Page 32 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818430
Page 33 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19 Illness]
Date of Diagnosis:
Jan/29/2021
3.Toxicity Grade: 1
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818431
Page 34 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818432
Page 35 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818433
Page 36 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818434
Page 37 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818435
Page 38 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818436
Page 39 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818437
Page 40 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818438
Page 41 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: [ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818439
Page 42 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818440
Page 43 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818441
Page 44 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818442
Page 45 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818443
Page 46 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818444
Page 47 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818445
Page 48 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818446
Page 49 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818447
Page 50 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/26/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818448
Page 51 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/26/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/26/2021
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 [BR7SMX]
5.bSample ID [BSGFPH]
5.cSample ID [BSGFPJ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818449
Page 52 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818450
Page 53 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818451
Page 54 of 227
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818452
Page 55 of 227
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Unplanned Assessments
1.Assessments
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818453
Page 56 of 227
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  left breast carcinoma  Jan/19/2021 UN
K:UNK YES  Repeating
Pages
 2.ADVERSE E
VENT 2  anemia  Feb/25/2021 U
NK:UNK YES  Repeating
Pages
 3.ADVERSE E
VENT 3  right axillary adenopathy with c
ortical thickening Jan/27/2021 UN
K:UNK YES  Repeating
Pages
 4.ADVERSE E
VENT 4  left axillary adenopathy with co
rtical thickening Jan/27/2021 UN
K:UNK YES  Repeating
Pages
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818454
Page 57 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[left breast carcinoma]
4.Start Date Time: Jan/19/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818455
Page 58 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Mitosis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021066056]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818456
Page 59 of 227
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[anemia]
4.Start Date Time: Feb/25/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818457
Page 60 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818458
Page 61 of 227
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[right axillary adenopathy with cortical thickening]
4.Start Date Time: Jan/27/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818459
Page 62 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818460
Page 63 of 227
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[left axillary adenopathy with cortical thickening]
4.Start Date Time: Jan/27/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818461
Page 64 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818462
Page 65 of 227
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818463
Page 66 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818464
Page 67 of 227
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818465
Page 68 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818466
Page 69 of 227
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818467
Page 70 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818468
Page 71 of 227
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818469
Page 72 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818470
Page 73 of 227
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818471
Page 74 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818472
Page 75 of 227
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Nov/13/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818473
Page 76 of 227
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818474
Page 77 of 227
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818475
Page 78 of 227
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818476
Page 79 of 227
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818477
Page 80 of 227
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818478
Page 81 of 227
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818479
Page 82 of 227
***Confidential***
 
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818480
Page 83 of 227
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818481
Page 84 of 227
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818482
Page 85 of 227
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/22/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818483
Page 86 of 227
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818484
Page 87 of 227
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818485
Page 88 of 227
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818486
Page 89 of 227
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/22/2021
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818487
Page 90 of 227
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818488
Page 91 of 227
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/22/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818489
Page 92 of 227
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/22/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818490
Page 93 of 227
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/22/2021
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 [BR7SDC]
5.bSample ID [BSGFKC]
5.cSample ID [BSGFKD]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818491
Page 94 of 227
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/22/2021
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 [BR7SDB]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818492
Page 95 of 227
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/22/2021 11:34
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818493
Page 96 of 227
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818494
Page 97 of 227
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/10/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818495
Page 98 of 227
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/10/2021
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 [BR7SK8]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818496
Page 99 of 227
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/10/2021 08:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818497
Page 100 of 227
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818498
Page 101 of 227
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/11/2021
3.Comments: [ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818499
Page 102 of 227
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818500
Page 103 of 227
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818501
Page 104 of 227
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818502
Page 105 of 227
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818503
Page 106 of 227
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Mar/11/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818504
Page 107 of 227
***Confidential***
 
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/13/2020
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818505
Page 108 of 227
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818506
Page 109 of 227
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4)
FDA-CBER-2021-5683-0818507
Page 110 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-25-2020 09:51:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0818508
Page 111 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-25-2020 09:51:48 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0818509
Page 112 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-08-2021 16:58:12 (UTC-06:00) Central
Time (US & Canada)
FormJan-29-2021 09:34:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0818510
Page 113 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-08-2021 16:58:12 (UTC-06:00) Central
Time (US & Canada)
1Jan-29-2021 09:34:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0818511
Page 114 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-08-2021 16:58:12 (UTC-06:00) Central
Time (US & Canada)
2Jan-29-2021 09:34:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0818512
Page 115 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-08-2021 16:58:12 (UTC-06:00) Central
Time (US & Canada)
3Jan-29-2021 09:34:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0818513
Page 116 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-08-2021 16:58:12 (UTC-06:00) Central
Time (US & Canada)
4Jan-29-2021 09:34:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0818514
Page 117 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Feb-08-2021 16:58:12 (UTC-06:00) Central
Time (US & Canada)
5Jan-29-2021 09:34:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0818515
Page 118 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Feb-08-2021 16:58:12 (UTC-06:00) Central
Time (US & Canada)
6Jan-29-2021 09:34:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0818516
Page 119 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
7Feb-08-2021 16:58:12 (UTC-06:00) Central
Time (US & Canada)
7Jan-29-2021 09:34:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0818517
Page 120 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
8Feb-08-2021 16:58:12 (UTC-06:00) Central
Time (US & Canada)
8Jan-29-2021 09:34:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0818518
Page 121 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
9Feb-08-2021 16:58:12 (UTC-06:00) Central
Time (US & Canada)
9Jan-29-2021 09:34:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0818519
Page 122 of 227
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormJan-22-2021 12:35:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0818520
Page 123 of 227
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Jan-29-2021 09:33:32 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephan Sharp  Approved Jan-25-2021 14:56:35 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephanSharp, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-22-2021 12:33:44 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephan Sharp  Approved Nov-13-2020 16:47:10 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephanSharp, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818521
Page 124 of 227
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
 N/A Nov-13-2020 10:00:34 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephan Sharp  Approved Nov-10-2020 15:02:09 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephanSharp, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818522
Page 125 of 227
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-25-2020 09:50:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-25-2020 09:50:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818523
Page 126 of 227
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-25-2020 09:50:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/25/2020Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818524
Page 127 of 227
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-25-2020 09:50:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11781257Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-25-2020 09:50:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1968Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-25-2020 09:51:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-25-2020 09:51:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-25-2020 09:51:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818525
Page 128 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-25-2020 09:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818526
Page 129 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-25-2020 09:51:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-25-2020 09:51:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-25-2020 09:51:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818527
Page 130 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-25-2020 09:52:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818528
Page 131 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020 09:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-25-2020 09:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
144.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-25-2020 09:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-25-2020 09:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
64.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-25-2020 09:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-25-2020 09:52:28
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24.7Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818529
Page 132 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-25-2020 09:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 96.1
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-25-2020 09:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-29-2020 00:16:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-28-2020 07:54:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Not clinically
significant per PI.
Sep-26-2020 06:01:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Confirmation
on the out of range
value as "clinically
significant" or "not
clinically
significant" is
expected as a
response. Please
review and confirm.
Sep-25-2020 09:53:27
(UTC-06:00) CentralACV0PFEINFP6000  Query 1: Answered Original value is
correct
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818530
Page 133 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada)
Sep-25-2020 09:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature 96.1 F
is outside of
Normal Range 97 -
99.5 F.
Sep-25-2020 09:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
96.1Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-25-2020 09:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-25-2020 09:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818531
Page 134 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-25-2020 09:52:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-25-2020 09:52:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-25-2020 09:52:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-25-2020 09:52:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-25-2020 09:52:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818532
Page 135 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-25-2020 09:52:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-25-2020 09:52:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-25-2020 09:52:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-25-2020 09:52:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818533
Page 136 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-25-2020 09:52:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-25-2020 09:52:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
99014Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818534
Page 137 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 10:08:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 10:08:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020 10:08:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-25-2020 10:08:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-25-2020 10:08:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020 10:08:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPW3JNInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818535
Page 138 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User ValueReason
Sep-28-2020
14:34:41
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Sep-28-2020
08:10:03
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dOriginal value is
correct
Sep-28-2020
05:33:24
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW4821297;The
Barcode BPW3JN is
recorded for two
subjects 11781256
and 11781257. Two
different subjects can
not have same
barcodes. Please
review and update as
appropriate.
Sep-25-2020
10:08:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BPW
3JNInitial Entry
5.b
Date Location User Value Reason
Sep-25-2020 10:08:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWPFNInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0818536
Page 139 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.b Sample ID
Date Location User ValueReason
Sep-28-2020
14:34:41
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Sep-28-2020
08:10:13
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dOriginal value is
correct
Sep-28-2020
05:37:20
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW4821295;The
Barcode BNWPFN is
recorded for two
subjects 11781256
and 11781257. Two
different subjects can
not have same
barcodes. Please
review and update as
appropriate.
Sep-25-2020
10:08:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BNW
PFNInitial Entry
5.c
Date Location User Value Reason
Sep-25-2020 10:08:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWPFPInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0818537
Page 140 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.c Sample ID
Date Location User ValueReason
Sep-28-2020
14:34:41
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Sep-28-2020
08:10:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dOriginal value is
correct
Sep-28-2020
05:34:54
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW4821296;The
Barcode BNWPFP is
recorded for two
subjects 11781256
and 11781257. Two
different subjects can
not have same
barcodes. Please
review and update as
appropriate.
Sep-25-2020
10:08:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BNW
PFPInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0818538
Page 141 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 10:09:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 10:09:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020 10:09:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-25-2020 10:09:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-25-2020 10:09:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020 10:09:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPW3JMInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818539
Page 142 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User ValueReason
Sep-28-2020
14:34:41
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Sep-28-2020
08:10:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dOriginal value is
correct
Sep-28-2020
05:31:45
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW4821298;The
Barcode BPW3JM is
recorded for two
subjects 11781256
and 11781257. Two
different subjects can
not have same
barcodes. Please
review and update as
appropriate.
Sep-25-2020
10:09:13
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BPW
3JMInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0818540
Page 143 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-25-2020 09:53:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-25-2020 09:53:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-25-2020 09:53:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-25-2020 09:53:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020 09:53Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-25-2020 09:53:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-25-2020 09:53:08
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818541
Page 144 of 227
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-25-2020 09:53:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-25-2020 09:53:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-25-2020 09:53:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818542
Page 145 of 227
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-25-2020 09:53:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818543
Page 146 of 227
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-16-2020 09:46:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818544
Page 147 of 227
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Oct-16-2020 09:46:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
2.a
Date Location User Value Reason
Oct-16-2020 09:46:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 98.0
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-16-2020 09:46:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-16-2020 09:46:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.0Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-16-2020 09:46:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818545
Page 148 of 227
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.a Temperature Location:
Date Location User Value Reason
Oct-16-2020 09:46:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818546
Page 149 of 227
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-16-2020 09:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-16-2020 09:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-16-2020 09:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-16-2020 09:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-16-2020 09:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818547
Page 150 of 227
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-16-2020 09:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-16-2020 09:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-16-2020 09:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-16-2020 09:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818548
Page 151 of 227
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 08:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 08:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 08:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-16-2020 08:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-16-2020 08:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
Oct-16-2020 08:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPW3W4Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818549
Page 152 of 227
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 08:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPW3W4Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818550
Page 153 of 227
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-16-2020 09:47:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-16-2020 09:47:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-16-2020 09:47:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-16-2020 09:47:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020 08:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-16-2020 09:47:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-16-2020 09:47:23
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818551
Page 154 of 227
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-16-2020 09:47:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-16-2020 09:47:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-16-2020 09:47:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818552
Page 155 of 227
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-13-2020 10:00:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/13/2020Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818553
Page 156 of 227
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-13-2020 11:32:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020 11:32:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020 11:32:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-13-2020 11:32:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-13-2020 11:32:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/13/2020Initial Entry
5.a
Date Location User Value Reason
Nov-13-2020 11:32:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR7GR4Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818554
Page 157 of 227
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Nov-13-2020 11:32:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR7GR4Initial Entry
5.b
Date Location User Value Reason
Nov-13-2020 11:32:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRVDK1Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-13-2020 11:32:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRVDK1Initial Entry
5.c
Date Location User Value Reason
Nov-13-2020 11:32:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRVDK2Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-13-2020 11:32:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRVDK2Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818555
Page 158 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-29-2021 12:00:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Jan-29-2021 09:33:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Jan-29-2021 09:33:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Jan-29-2021 09:33:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/29/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-29-2021 09:33:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818556
Page 159 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/29/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/28/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-08-2021 17:01:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolve
d:
Jan/30/2021New Information
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Jan-29-2021 09:34:06 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0818557
Page 160 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-06:00) Central
Time (US & Canada)FEVER
4.a Was symptom present?
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom
Present:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATHInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818558
Page 161 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sympto
m Prese
nt:NO
4.c Symptoms:
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORT
NESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818559
Page 162 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAIN
Symptom
Present:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW LOSS OF TA
STE OR SMELL
Symptom
Present:YESInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818560
Page 163 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
4.f Symptoms:
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SM
ELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.g
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818561
Page 164 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Present
:NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jan-29-2021 09:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818562
Page 165 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a
Date Location User Value Reason
Jan-29-2021 09:34:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Oth
er:congestion, na
salInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Jan-29-2021 09:34:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
congestion, nasalInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818563
Page 166 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Feb-08-2021 17:00:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818564
Page 167 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Feb-08-2021 17:00:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/29/2021Initial Entry
Feb-08-2021 16:58:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Jan-29-2021 09:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-08-2021 17:00:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
Feb-08-2021 16:58:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Jan-29-2021 09:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-08-2021 17:00:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
Feb-08-2021 16:58:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Jan-29-2021 09:34:53
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818565
Page 168 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada)
4. Assay Code and Description:
Date Location User Value Reason
Feb-08-2021 17:00:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2Initial Entry
Feb-08-2021 16:58:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Jan-29-2021 09:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Device Type:
Date Location User Value Reason
Feb-08-2021 17:00:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TE
STInitial Entry
Feb-08-2021 16:58:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Jan-29-2021 09:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Trade Name:
Date Location User Value Reason
Feb-08-2021 17:00:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
THERMOFISHER APPL BIO T
AQPATH COVID-19 COMBO K
ITInitial Entry
Feb-08-2021 16:58:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818566
Page 169 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jan-29-2021 09:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
7. Test Result:
Date Location User Value Reason
Feb-08-2021 17:00:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
POSITIVEInitial Entry
Feb-08-2021 16:58:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Jan-29-2021 09:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Feb-08-2021 16:58:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Jan-29-2021 09:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Feb-08-2021 16:58:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Jan-29-2021 09:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818567
Page 170 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: 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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-29-2021 12:00:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-29-2021 12:00:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-29-2021 12:00:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-29-2021 12:00:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-29-2021 12:00:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/29/2021Initial Entry
5.a
Date Location User Value Reason
Jan-29-2021 12:00:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: CV46946Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818568
Page 171 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: 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: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Jan-29-2021 12:00:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CV46946Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818569
Page 172 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-29-2021 09:35:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-29-2021 09:35:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-29-2021 09:35:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Jan-29-2021 09:35:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Telehealth VisitInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818570
Page 173 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.a
Date Location User Value Reason
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits
or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitio
ner:EMERGEN
CY ROOM
Occurrence of Vis
its or Contacts:NOInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818571
Page 174 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Conta
cts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818572
Page 175 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Feb-10-2021 11:43:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practit
ioner:URGENT CA
RE
Occurrence of
Visits or Conta
cts:YES
Number of Vis
its or Contact
s:
1New Information
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitione
r:URGENT
CARE
Occurrence of Visit
s or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-10-2021 11:43:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1New Information
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ONInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818573
Page 176 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Occurrence of
Visits or Conta
cts:NO
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits or
Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818574
Page 177 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Jan-29-2021 09:35:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818575
Page 178 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Jan-29-2021 09:35:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNES
SInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Mar-04-2021 08:49:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-03-2021 11:35:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Mar-03-2021 11:35:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness Diagnosis:
COVID-19 Illness
Date of Diagnosis:
Jan/29/2021Transcription Error
Mar-03-2021 11:03:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical Query:
Date of collection
for positive local
test was 29Jan2021,
please consider
updating date of
diagnosis to match.
Feb-08-2021 17:05:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness Diagnosis:
COVID-19 IllnessNew Information
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818576
Page 179 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Diagnosis:
Jan/30/2021
Jan-29-2021 09:35:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Jan-29-2021 09:35:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818577
Page 180 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/26/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021 08:55:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/26/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-26-2021 08:55:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818578
Page 181 of 227
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/26/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021 11:33:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021 11:33:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021 11:33:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-26-2021 11:33:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-26-2021 11:33:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/26/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021 11:33:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR7SMXInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818579
Page 182 of 227
***Confidential***
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/26/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Feb-26-2021 11:33:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR7SMXInitial Entry
5.b
Date Location User Value Reason
Feb-26-2021 11:33:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSGFPHInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-26-2021 11:33:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSGFPHInitial Entry
5.c
Date Location User Value Reason
Feb-26-2021 11:33:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSGFPJInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-26-2021 11:33:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSGFPJInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818580
Page 183 of 227
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Jan-22-2021 12:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818581
Page 184 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Mar-03-2021 13:36:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818582
Page 185 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Mar-11-2021 14:50:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818583
Page 186 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Mar-11-2021 14:51:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818584
Page 187 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Jan-22-2021 12:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-22-2021 12:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-22-2021 12:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
left breast carcinomaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-22-2021 12:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-22-2021 12:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-22-2021 12:33:44
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
3Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818585
Page 188 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada)
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-26-2021 08:56:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed SDB updated
Jan-25-2021 08:28:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered SAE information to
be uploaded shortly.
Jan-25-2021 07:22:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE RECON: left
breast
carcinoma(Onset
date:19Jan2021) is
not reported to
Safety database but
marked serious on
AE CRF. Confirm
seriousness and
report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Jan-25-2021 07:22:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted Query can be
addressed internally
Jan-22-2021 12:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE left breast
carcinoma: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818586
Page 189 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jan-22-2021 12:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
NO
Did this serious event require
or prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous event
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-22-2021 12:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818587
Page 190 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jan-22-2021 12:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
MitosisInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-22-2021 12:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-22-2021 12:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-22-2021 12:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-22-2021 12:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818588
Page 191 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jan-22-2021 12:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-01-2021 08:51:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021066056Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0818589
Page 192 of 227
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Mar-03-2021 13:36:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-03-2021 13:36:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-03-2021 13:36:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
anemiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-03-2021 13:36:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/25/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-03-2021 13:36:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818590
Page 193 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Mar-03-2021 13:36:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-03-2021 13:36:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-03-2021 13:36:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-03-2021 13:36:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-03-2021 13:36:15
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818591
Page 194 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-03-2021 13:36:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-03-2021 13:36:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-03-2021 13:36:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-03-2021 13:36:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818592
Page 195 of 227
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Mar-11-2021 14:50:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-11-2021 14:50:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-11-2021 14:50:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
right axillary adenopathy with co
rtical thickeningInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-11-2021 14:50:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 14:50:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818593
Page 196 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Mar-11-2021 14:50:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-11-2021 14:50:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-11-2021 14:50:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-11-2021 14:50:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-11-2021 14:50:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818594
Page 197 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Mar-11-2021 14:50:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-11-2021 14:50:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021 14:50:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-11-2021 14:50:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818595
Page 198 of 227
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Mar-11-2021 14:51:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-11-2021 14:51:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-11-2021 14:51:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
left axillary adenopathy with cort
ical thickeningInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-11-2021 14:51:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 14:51:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818596
Page 199 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Mar-11-2021 14:51:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-11-2021 14:51:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-11-2021 14:51:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-11-2021 14:51:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-11-2021 14:51:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818597
Page 200 of 227
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Mar-11-2021 14:51:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-11-2021 14:51:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021 14:51:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-11-2021 14:51:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818598
Page 201 of 227
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-13-2020 10:00:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-13-2020 10:00:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-13-2020 10:00:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818599
Page 202 of 227
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-22-2021 12:34:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818600
Page 203 of 227
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-22-2021 12:35:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-22-2021 12:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-22-2021 12:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible per local/national rec
ommendations and confirmed
to have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818601
Page 204 of 227
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-22-2021 12:35:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-22-2021 12:35:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818602
Page 205 of 227
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-25-2021 17:33:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-25-2021 08:29:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered SWABs have been
entered.
Jan-25-2021 04:47:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly
consider to update
missing SWAB
PFE and SAMP
TRK forms or else
clarify. Thank you.
Jan-22-2021 12:35:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818603
Page 206 of 227
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-22-2021 12:35:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/22/2021Initial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818604
Page 207 of 227
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-22-2021 12:36:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-22-2021 12:36:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-22-2021 12:36:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818605
Page 208 of 227
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-22-2021 12:36:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-22-2021 12:36:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-22-2021 12:36:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-22-2021 12:36:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-22-2021 12:36:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818606
Page 209 of 227
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jan-22-2021 12:36:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-22-2021 12:36:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-22-2021 12:36:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Jan-22-2021 12:36:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818607
Page 210 of 227
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-25-2021 08:28:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-25-2021 08:28:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-25-2021 08:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-25-2021 08:28:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-25-2021 08:28:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/22/2021Initial Entry
5.a
Date Location User Value Reason
Jan-25-2021 08:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR7SDCInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818608
Page 211 of 227
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Jan-25-2021 08:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR7SDCInitial Entry
5.b
Date Location User Value Reason
Jan-25-2021 08:29:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSGFKCInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-25-2021 08:29:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSGFKCInitial Entry
5.c
Date Location User Value Reason
Jan-25-2021 08:29:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSGFKDInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-25-2021 08:29:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSGFKDInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (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-2021-5683-0818609
Page 212 of 227
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-25-2021 08:28:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-25-2021 08:28:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-25-2021 08:28:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-25-2021 08:28:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-25-2021 08:28:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/22/2021Initial Entry
5.a
Date Location User Value Reason
Jan-25-2021 08:28:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR7SDBInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818610
Page 213 of 227
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Jan-25-2021 08:28:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR7SDBInitial Entry
090177e196ae3fb9\Final\Final On: 01-Apr-2021 05:22 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0818611
Page 214 of 227
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1178 Site Name: (1178) Clinical Research Associates Inc
Subject No: 11781257 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-22-2021 12:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-22-2021 12:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-22-2021 12:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-22-2021 12:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021 11:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-22-2021 12
…[truncated]