125742 S1 M5 CRF c4591001 1071 10711171

Document text

Page 1 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919405
Page 2 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/15/2020
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919406
Page 3 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10711171]
2.Birth Date: /1979
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:
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919407
Page 4 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919408
Page 5 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919409
Page 6 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919410
Page 7 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TYPE II DIABETES]
Start Date: UNK/UNK/2019
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OBESITY]
Start Date: UNK/UNK/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALLERGY TO CYCLOBENZAPRINE]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919411
Page 8 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
2.Weight: [84.8]
3.Unit: kg
4.Height: [158.8]
5.Unit: cm
6.Body Mass Index: [33.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919412
Page 9 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/15/2020
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:
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919413
Page 10 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/15/2020
2.Randomization Number: [90848]
3.Randomization Group: [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919414
Page 11 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTL9K]
5.bSample ID [BPRKZZ]
5.cSample ID [BPRL00]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919415
Page 12 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTLB4]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919416
Page 13 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/15/2020 16:15
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
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919417
Page 14 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919418
Page 15 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919419
Page 16 of 169
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Oct/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919420
Page 17 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/5/2020
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:
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919421
Page 18 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/5/2020
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 [BPTLGX]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919422
Page 19 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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/5/2020 17:20
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
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919423
Page 20 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919424
Page 21 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/3/2020
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 [BRJ0X9]
5.bSample ID [BSMZLF]
5.cSample ID [BSMZLG]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919425
Page 22 of 169
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919426
Page 23 of 169
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919427
Page 24 of 169
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919428
Page 25 of 169
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919429
Page 26 of 169
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919430
Page 27 of 169
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919431
Page 28 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/22/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919432
Page 29 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/22/2020
2.Date of First Symptom Started: Nov/21/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/27/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
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? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919433
Page 30 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Symptoms - Other
5.aSymptoms - Other Text: [HEADACHE]
5.bSymptoms - Other Text: [FATIGUE]
5.cSymptoms - Other Text: [NASAL CONGESTION]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919434
Page 31 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Nov/23/20
20 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919435
Page 32 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/23/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: CDC 2019-NCOV REAL-TIME RT-PCR DIAGNOSTIC PANEL
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919436
Page 33 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Nov/22/2020
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 [CV16001]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919437
Page 34 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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:[VISIT CONDUCTED VIA TELEHEALTH]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919438
Page 35 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
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
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919439
Page 36 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919440
Page 37 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919441
Page 38 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 2
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919442
Page 39 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919443
Page 40 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919444
Page 41 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919445
Page 42 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919446
Page 43 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#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
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919447
Page 44 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919448
Page 45 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919449
Page 46 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919450
Page 47 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919451
Page 48 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919452
Page 49 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919453
Page 50 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919454
Page 51 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919455
Page 52 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919456
Page 53 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919457
Page 54 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919458
Page 55 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/22/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/22/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919459
Page 56 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/22/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/22/2020
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 [BSGS4P]
5.bSample ID [BSGS4R]
5.cSample ID [BSGS4S]
5.dSample ID [BSGS4T]
5.eSample ID [BPTLRG]
5.fSample ID [BPTLRH]
5.gSample ID [BPTLRJ]
5.hSample ID [BPTLRK]
5.iSample ID [BPTLRL]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919460
Page 57 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919461
Page 58 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919462
Page 59 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919463
Page 60 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919464
Page 61 of 169
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  SWOLLEN LYMPH NODE UN
DER LEFT ARMPIT Oct/7/2020 U
NK:UNK NO
End Date Time:
Oct/12/2020 UNK:U
NK
 Repeating
Pages
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919465
Page 62 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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)[SWOLLEN LYMPH NODE UNDER LEFT ARMPIT]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/12/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919466
Page 63 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919467
Page 64 of 169
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919468
Page 65 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919469
Page 66 of 169
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919470
Page 67 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: //
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919471
Page 68 of 169
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919472
Page 69 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919473
Page 70 of 169
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919474
Page 71 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919475
Page 72 of 169
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919476
Page 73 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919477
Page 74 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Nov/3/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919478
Page 75 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919479
Page 76 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919480
Page 77 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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:
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919481
Page 78 of 169
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919482
Page 79 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919483
Page 80 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919484
Page 81 of 169
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919485
Page 82 of 169
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919486
Page 83 of 169
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919487
Page 84 of 169
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919488
Page 85 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919489
Page 86 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919490
Page 87 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919491
Page 88 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/26/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919492
Page 89 of 169
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919493
Page 90 of 169
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919494
Page 91 of 169
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/3/2020
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919495
Page 92 of 169
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919496
Page 93 of 169
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael Dunn  Approved Mar-10-2021 10:15:41 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDunn, 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.
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919497
Page 94 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-16-2020 09:33:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919498
Page 95 of 169
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael Dunn  Approved Mar-10-2021 10:15:41 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDunn, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-15-2021 17:33:59 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dunn  Approved Jan-20-2021 15:53:55 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDunn, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-23-2020 10:58:03 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919499
Page 96 of 169
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Michael Dunn  Approved Dec-18-2020 12:36:47 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDunn, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-23-2020 09:47:08 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dunn  Approved Nov-13-2020 09:29:42 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDunn, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-10-2020 10:13:48 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dunn  Approved Nov-09-2020 16:18:36 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919500
Page 97 of 169
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Affidavit:
By my dated signature below, I, MichaelDunn, 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.
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919501
Page 98 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-16-2020 09:28:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-16-2020 09:28:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919502
Page 99 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-16-2020 09:28:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/15/2020Initial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919503
Page 100 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-16-2020 09:27:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10711171Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-16-2020 09:27:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1979Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-16-2020 09:28:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-16-2020 09:28:32
(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-16-2020 09:28:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919504
Page 101 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-16-2020 09:32:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919505
Page 102 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-16-2020 09:33:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-16-2020 09:33:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-16-2020 09:33:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919506
Page 103 of 169
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Sep-16-2020 09:33:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:TYPE II DIAB
ETES
Start Date: UNK/UNK/201
9
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-16-2020 09:33:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 09:33:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TYPE II DIABETESInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-16-2020 09:33:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-16-2020 09:33:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919507
Page 104 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b
Date Location User Value Reason
Sep-16-2020 09:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History T
erm:OBESITY
Start Date: UNK/UNK/2
019
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-16-2020 09:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 09:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBESITYInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-16-2020 09:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-16-2020 09:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919508
Page 105 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-24-2020 11:40:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:ALLERGY TO CY
CLOBENZAPRINE
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-24-2020 11:40:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-24-2020 11:40:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ALLERGY TO CYCLOBENZAP
RINEInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-24-2020 11:40:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-24-2020 11:40:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919509
Page 106 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-16-2020 09:37:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-16-2020 09:37:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
84.8Initial Entry
3. Unit:
Date Location User Value Reason
Sep-16-2020 09:37:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-16-2020 09:37:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
158.8Initial Entry
5. Unit:
Date Location User Value Reason
Sep-16-2020 09:37:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-16-2020 09:37:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
33.6Initial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919510
Page 107 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7.a
Date Location User Value Reason
Sep-16-2020 09:37:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 37.4
Temperature Unit: C
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-16-2020 09:37:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-16-2020 09:37:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
37.4Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-16-2020 09:37:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-16-2020 09:37:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919511
Page 108 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-16-2020 09:37:55
(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-16-2020 09:37:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-16-2020 09:37:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-16-2020 09:37:55
(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-16-2020 09:37:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-16-2020 09:37:55
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919512
Page 109 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-16-2020 09:37:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-16-2020 09:37:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-16-2020 09:37:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919513
Page 110 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-16-2020 09:38:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-16-2020 09:38:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
90848Initial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919514
Page 111 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 09:38:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 09:38:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020 09:38:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-16-2020 09:38:14
(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-16-2020 09:38:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020 09:38:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPTL9KInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919515
Page 112 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Sep-16-2020 09:38:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPTL9KInitial Entry
5.b
Date Location User Value Reason
Sep-16-2020 09:38:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRKZZInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-16-2020 09:38:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRKZZInitial Entry
5.c
Date Location User Value Reason
Sep-16-2020 09:39:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRL00Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-16-2020 09:39:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRL00Initial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919516
Page 113 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 09:39:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 09:39:17
(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-16-2020 09:40:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-16-2020 09:39:17
(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-16-2020 09:39:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020 09:40:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPTLB4Initial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919517
Page 114 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Sep-16-2020 09:40:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPTLB4Initial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919518
Page 115 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-16-2020 09:40:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-16-2020 09:40:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-16-2020 09:40:31
(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-16-2020 09:40:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020 16:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-16-2020 09:40:31
(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-16-2020 09:40:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919519
Page 116 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Route:
Date Location User Value Reason
Sep-16-2020 09:40:31
(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-16-2020 09:40:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-16-2020 09:40:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919520
Page 117 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-16-2020 09:40:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919521
Page 118 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020 10:06:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/5/2020Initial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919522
Page 119 of 169
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Oct-06-2020 10:06:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/5/2020Initial Entry
2.a
Date Location User Value Reason
Oct-06-2020 10:06:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.8
Temperature Unit: C
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-06-2020 10:06:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-06-2020 10:06:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
36.8Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-06-2020 10:06:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919523
Page 120 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-06-2020 10:06:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919524
Page 121 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-06-2020 10:06:33
(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-06-2020 10:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-06-2020 10:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/5/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-06-2020 10:06:33
(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-06-2020 10:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-06-2020 10:06:33
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919525
Page 122 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-06-2020 10:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-06-2020 10:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-06-2020 10:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919526
Page 123 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020 10:06:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020 10:06:44
(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-06-2020 10:06:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-06-2020 10:06:44
(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-06-2020 10:06:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/5/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020 10:06:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPTLGXInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919527
Page 124 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Oct-06-2020 10:06:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPTLGXInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919528
Page 125 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-06-2020 10:07:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-06-2020 10:07:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-06-2020 10:07:17
(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-06-2020 10:07:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/5/2020 17:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-06-2020 10:07:17
(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-06-2020 10:07:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919529
Page 126 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Route:
Date Location User Value Reason
Oct-06-2020 10:07:17
(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-06-2020 10:07:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-06-2020 10:07:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919530
Page 127 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-04-2020 08:37:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/3/2020Initial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919531
Page 128 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-04-2020 08:37:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-04-2020 08:37:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-04-2020 08:37:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-04-2020 08:37:35
(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-04-2020 08:37:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/3/2020Initial Entry
5.a
Date Location User Value Reason
Nov-04-2020 08:37:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRJ0X9Initial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919532
Page 129 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Nov-04-2020 08:37:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRJ0X9Initial Entry
5.b
Date Location User Value Reason
Nov-04-2020 08:37:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSMZLFInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-04-2020 08:37:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSMZLFInitial Entry
5.c
Date Location User Value Reason
Nov-04-2020 08:38:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSMZLGInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-04-2020 08:38:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSMZLGInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919533
Page 130 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-01-2020 04:19:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Nov-30-2020 09:22:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered UPDATES MADE
Nov-26-2020 04:14:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened DM: Kindly review
and complete
‘Health Care
Utilization,
Microbiology
Specimen form' at
this visit. Thank
you.
Nov-25-2020 09:37:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-24-2020 03:12:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 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.
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-23-2020 09:48:02
(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
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0919534
Page 131 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
as appropriate.
Nov-23-2020 09:48:02
(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.
Nov-23-2020 09:48:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/22/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-23-2020 09:48:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919535
Page 132 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-23-2020 09:48:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-23-2020 09:48:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/22/2020Transcription Error
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of assessment
is not same as Date
Visit. Please check
and correct.
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/21/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Dec-04-2020 09:07:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/21/2020Transcription Error
Dec-03-2020 12:00:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/27/2020New Information
Nov-23-2020 09:49:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/21/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Dec-04-2020 09:08:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolved
:Transcription Error
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919536
Page 133 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Nov/27/2020
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:YESInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919537
Page 134 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.b Symptoms:
Date Location User Value Reason
Nov-23-2020 09:48:35
(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
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORTN
ESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919538
Page 135 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAIN
Symptom
Present:YESInitial Entry
4.e Symptoms:
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSCLE
PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.f
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919539
Page 136 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREASE
D SORE THROAT
Symptom
Present:YESInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919540
Page 137 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.g Symptoms:
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE TH
ROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHEA
Symptom Present: YESInitial Entry
4.h Symptoms:
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.i
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919541
Page 138 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
4.i Symptoms:
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-23-2020 09:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Nov-23-2020 09:49:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other
:HEADACH
EInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Nov-23-2020 09:49:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
5.b
Date Location User Value Reason
Nov-23-2020 09:49:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other: FATIGUEInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Nov-23-2020 09:49:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919542
Page 139 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.c
Date Location User Value Reason
Dec-04-2020 09:07:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - O
ther:NASAL CONGE
STIONInitial Entry
5.c Symptoms - Other Text:
Date Location User Value Reason
Dec-04-2020 09:07:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NASAL CONGESTIONInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919543
Page 140 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Nov-30-2020 09:22:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919544
Page 141 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-30-2020 09:22:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/23/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-30-2020 09:22:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-30-2020 09:22:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-30-2020 09:22:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Nov-30-2020 09:22:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Nov-30-2020 09:22:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CDC 2019-NCOV REAL-TIME R
T-PCR DIAGNOSTIC PANELInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919545
Page 142 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Test Result:
Date Location User Value Reason
Nov-30-2020 09:22:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919546
Page 143 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-25-2020 09:37:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-25-2020 09:37:13
(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
Dec-06-2020 23:30:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Closed as data
updated.
Dec-04-2020 09:07:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Answer Auto Query
Dec-03-2020 23:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened DM: Date of
Collection
22-Nov-2020 is
before Date of First
Symptom Started
27-Nov-2020 on the
Signs and
Symptoms form in
the same visit.
Please review and
update as
appropriate.
Dec-03-2020 16:00:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered QUERY IN
ERROR. DATES
MATCH
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0919547
Page 144 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Dec-03-2020 12:00:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Date of Collection
is before Date of
First Symptom
Started on the Signs
and Symptoms form
in the same visit.
Please review and
update as
appropriate.
Nov-25-2020 09:37:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-25-2020 09:37:13
(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-25-2020 09:37:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/22/2020Initial Entry
5.a
Date Location User Value Reason
Nov-25-2020 09:37:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: CV16001Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-25-2020 09:37:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CV16001Initial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919548
Page 145 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-25-2020 09:37:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-25-2020 09:37:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-25-2020 09:37:45
(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
Nov-25-2020 09:37:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VISIT CONDUCTED VIA TELE
HEALTHInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919549
Page 146 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Nov-30-2020 09:22:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits o
r Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-30-2020 09:22:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-30-2020 09:22:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Nov-30-2020 09:22:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practition
er:EMERGENC
Y ROOM
Occurrence of Visi
ts or Contacts:NOInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919550
Page 147 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-30-2020 09:22:24
(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
Nov-30-2020 09:22:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Nov-30-2020 09:22:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of V
isits or Contacts
:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-30-2020 09:22:24
(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
Nov-30-2020 09:22:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919551
Page 148 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Nov-30-2020 09:22:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-30-2020 09:22:24
(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
Nov-30-2020 09:22:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Nov-30-2020 09:22:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Contac
ts:NOInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919552
Page 149 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Nov-30-2020 09:22:24
(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
Nov-30-2020 09:22:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Nov-30-2020 09:22:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or C
ontacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Nov-30-2020 09:22:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-30-2020 09:22:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Nov-30-2020 09:22:24
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919553
Page 150 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919554
Page 151 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/22/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Nov-25-2020 09:38:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Nov-25-2020 09:38:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Nov-25-2020 09:38:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919555
Page 152 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/22/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-24-2020 09:00:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Dec-23-2020 23:08:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened DM: Erroneous visit
is marked. Please
confirm if this visit
occurred. If yes,
kindly untick
erroneous visit
button. If not
occurred, kindly
erase data from
SAMP TRK form
and mark the form
as Not Done/Not
Applicable at form
level comment or
else clarify.
Dec-23-2020 10:58:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please check
whether other
assessments are
performed at this
visit.
Dec-23-2020 10:58:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/22/2020New Information
Nov-24-2020 03:13:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted No other forms
initiated
Nov-23-2020 09:47:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please check
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0919556
Page 153 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/22/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
whether other
assessments are
performed at this
visit.
Nov-23-2020 09:47:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/22/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Dec-24-2020 09:00:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Nov-23-2020 09:47:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-23-2020 10:58:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
Nov-23-2020 09:47:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Nov-23-2020 09:47:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919557
Page 154 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/22/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-23-2020 10:58:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-23-2020 10:58:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-23-2020 10:58:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-23-2020 10:58:32
(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.
Dec-23-2020 10:58:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/22/2020Initial Entry
5.a
Date Location User Value Reason
Dec-23-2020 10:58:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSGS4PInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919558
Page 155 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/22/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Dec-23-2020 10:58:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSGS4PInitial Entry
5.b
Date Location User Value Reason
Dec-23-2020 10:58:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSGS4RInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-23-2020 10:58:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSGS4RInitial Entry
5.c
Date Location User Value Reason
Dec-23-2020 10:58:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSGS4SInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-23-2020 10:58:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSGS4SInitial Entry
5.d
Date Location User Value Reason
Dec-23-2020 10:59:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSGS4TInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919559
Page 156 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/22/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.d Sample ID
Date Location User Value Reason
Dec-23-2020 10:59:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSGS4TInitial Entry
5.e
Date Location User Value Reason
Dec-23-2020 11:00:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPTLRGInitial Entry
5.e Sample ID
Date Location User Value Reason
Dec-23-2020 11:00:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPTLRGInitial Entry
5.f
Date Location User Value Reason
Dec-23-2020 11:01:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPTLRHInitial Entry
5.f Sample ID
Date Location User Value Reason
Dec-23-2020 11:01:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPTLRHInitial Entry
5.g
Date Location User Value Reason
Dec-23-2020 11:01:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPTLRJInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919560
Page 157 of 169
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/22/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.g Sample ID
Date Location User Value Reason
Dec-23-2020 11:01:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPTLRJInitial Entry
5.h
Date Location User Value Reason
Dec-23-2020 11:01:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPTLRKInitial Entry
5.h Sample ID
Date Location User Value Reason
Dec-23-2020 11:01:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPTLRKInitial Entry
5.i
Date Location User Value Reason
Dec-23-2020 11:02:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPTLRLInitial Entry
5.i Sample ID
Date Location User Value Reason
Dec-23-2020 11:02:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPTLRLInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919561
Page 158 of 169
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Oct-30-2020 09:26:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919562
Page 159 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Oct-30-2020 09:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-30-2020 09:26:46
(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
Nov-10-2020 10:13:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWOLLEN LYMPH NODE UND
ER LEFT ARMPITChanged
Information
Oct-30-2020 09:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWOLLEN LYMPHNODE UND
ER LEFT ARMPITInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-30-2020 09:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-06-2020 09:32:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-06-2020 09:32:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:Transcription Error
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919563
Page 160 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct/12/2020 UNK:UNK
Nov-06-2020 09:31:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For SWOLLEN
LYMPHNODE
UNDER LEFT
ARMPIT End Date
12/Nov/2020, is a
future date relative to
when it was entered
on 06/Nov/2020.
Please correct.
Nov-06-2020 09:31:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/12/2020 UNK:UNKNew Information
Oct-30-2020 09:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-30-2020 09:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-30-2020 09:26:46
(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
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919564
Page 161 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-30-2020 09:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-30-2020 09:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-30-2020 09:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-30-2020 09:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-30-2020 09:26:46
(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
Nov-06-2020 09:33:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-06-2020 09:33:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDTranscription Error
Nov-06-2020 09:31:47 ACV0PFEINFP6000  auto query Query 1: Opened For AE SWOLLEN
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919565
Page 162 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-06:00) Central
Time (US & Canada)(autoquery) LYMPHNODE
UNDER LEFT
ARMPIT: Response
to "What was the
outcome of this
adverse event?" is
'Not Recovered/Not
Resolved' but AE
End Date/Time is
present.
Oct-30-2020 09:26:46
(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
Oct-30-2020 09:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919566
Page 163 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-04-2020 08:38:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-04-2020 08:38:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-04-2020 08:38:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919567
Page 164 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-15-2021 17:34:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/26/2021Initial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919568
Page 165 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-24-2021 16:42:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed to
have received only placebo at V
accination 1/2Changed
Information
Feb-15-2021 17:34:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is NOT willing to retur
n for Vaccination 3 OR otherwise
not eligibleInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919569
Page 166 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-15-2021 17:33:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/26/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Feb-24-2021
22:32:17
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_35
Feb-24-2021
16:42:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dChanged data per query
Feb-22-2021
10:23:13
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7349795;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Feb-15-2021
17:33:59
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000  Data
Entry
:
ASSE
SS ELInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919570
Page 167 of 169
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Canada) IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ON
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919571
Page 168 of 169
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-04-2020 08:38:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-16-2020 09:38:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-16-2020 09:33:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-04-2020 08:38:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/3/2020Initial Entry
Nov-04-2020 08:38:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/15/2020Initial Entry
Sep-16-2020 09:38:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/15/2020Initial Entry
Sep-16-2020 09:33:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/15/2020Initial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919572
Page 169 of 169
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711171 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020 15:39:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3f11\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919573