Document text
Page 1 of 192
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911481
Page 2 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/20/2020
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911482
Page 3 of 192
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10471012]
2.Birth Date: /1962
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:
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0911483
Page 4 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/20/2020
2.Erroneous Visit
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911484
Page 5 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911485
Page 6 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911486
Page 7 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[hypothyriodism]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[migraines]
Start Date: UNK/UNK/2003
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[hysterectomy]
Start Date: Dec/UNK/2003
Ongoing: NO
End Date:
Dec/UNK/2003
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[dysfunctional gallbladder]
Start Date: UNK/UNK/2018
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[obesity]
Start Date: UNK/UNK/1992
Ongoing: YES
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911487
Page 8 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[depression]
Start Date: UNK/UNK/2008
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[allergy to sulfa]
Start Date: UNK/UNK/2013
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[cholecystectomy]
Start Date: Feb/UNK/2018
Ongoing: NO
End Date:
Feb/UNK/2018
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[gastric bypass]
Start Date: Jun/UNK/2001
Ongoing: NO
End Date:
Jun/UNK/2001
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911488
Page 9 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/20/2020
2.Weight: [237.8]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [35.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911489
Page 10 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911490
Page 11 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/20/2020
2.Randomization Number: [233930]
3.Randomization Group: [ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911491
Page 12 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/20/2020
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 [BN5XM0]
5.bSample ID [BN5XM1]
5.cSample ID [BN5XM2]
5.dSample ID [BLB675]
5.eSample ID [BLB676]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911492
Page 13 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/20/2020
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 [BN5XP0]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911493
Page 14 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/20/2020 12:29
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
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911494
Page 15 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911495
Page 16 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911496
Page 17 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911497
Page 18 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911498
Page 19 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/8/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BJLLS5]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911499
Page 20 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/8/2020 19:58
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
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911500
Page 21 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911501
Page 22 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/26/2020
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 [BPSZ4L]
5.bSample ID [BPSZ4M]
5.cSample ID [BPSZ4N]
5.dSample ID [BSHNX5]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911502
Page 23 of 192
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911503
Page 24 of 192
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/11/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJ2NM]
5.bSample ID [BRJ2NN]
5.cSample ID [BRJ2NP]
5.dSample ID [BLB6VC]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911504
Page 25 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911505
Page 26 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911506
Page 27 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911507
Page 28 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911508
Page 29 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911509
Page 30 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/12/2020
2.Date of First Symptom Started: Oct/5/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/14/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911510
Page 31 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locati
onAssay Code and Descripti
onDevice Typ
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911511
Page 32 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911512
Page 33 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/12/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV16937]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911513
Page 34 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:[no office visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911514
Page 35 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911515
Page 36 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911516
Page 37 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911517
Page 38 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911518
Page 39 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911519
Page 40 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911520
Page 41 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
1. Sponsor-Defined Ident
ifierTest
:Resul
t:Repeating
Pages
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911521
Page 42 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911522
Page 43 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911523
Page 44 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911524
Page 45 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911525
Page 46 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: [ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911526
Page 47 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911527
Page 48 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911528
Page 49 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911529
Page 50 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911530
Page 51 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911531
Page 52 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911532
Page 53 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911533
Page 54 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911534
Page 55 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/13/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/13/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911535
Page 56 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/13/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/13/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPSXXF]
5.bSample ID [BPSXXG]
5.cSample ID [BPSXXH]
5.dSample ID [BSHP4N]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911536
Page 57 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911537
Page 58 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911538
Page 59 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/26/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911539
Page 60 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911540
Page 61 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911541
Page 62 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911542
Page 63 of 192
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
1.ADVERSE EVE
NT 1 Syncope episod
es Feb/19/2021 UNK:U
NK NO
End Date Time:
Feb/21/2021 UNK:UNK
Repeating
Pages
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911543
Page 64 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Syncope episodes]
4.Start Date Time: Feb/19/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/21/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Stress]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911544
Page 65 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911545
Page 66 of 192
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911546
Page 67 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911547
Page 68 of 192
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
1. Repeating
Pages
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911548
Page 69 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: //
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911549
Page 70 of 192
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911550
Page 71 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911551
Page 72 of 192
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911552
Page 73 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911553
Page 74 of 192
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911554
Page 75 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911555
Page 76 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911556
Page 77 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911557
Page 78 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911558
Page 79 of 192
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911559
Page 80 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911560
Page 81 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911561
Page 82 of 192
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911562
Page 83 of 192
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911563
Page 84 of 192
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911564
Page 85 of 192
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911565
Page 86 of 192
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911566
Page 87 of 192
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911567
Page 88 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/2/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911568
Page 89 of 192
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911569
Page 90 of 192
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911570
Page 91 of 192
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/26/2020
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911571
Page 92 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911572
FDA-CBER-2021-5683-0911573
Page 94 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-20-2020 14:11:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911574
Page 95 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Aug-20-2020 14:17:41 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911575
Page 96 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-08-2020 19:59:40 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911576
Page 97 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-08-2020 19:59:40 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911577
Page 98 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-08-2020 19:59:40 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911578
Page 99 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-08-2020 19:59:40 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911579
Page 100 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-08-2020 19:59:40 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911580
Page 101 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-08-2020 19:59:40 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911581
Page 102 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-08-2020 19:59:40 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911582
Page 103 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-08-2020 19:59:40 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911583
Page 104 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-08-2020 19:59:40 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911584
Page 105 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-20-2020 15:03:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0911585
Page 106 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-20-2020 15:03:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0911586
Page 107 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-20-2020 15:03:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0911587
Page 108 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-20-2020 15:03:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0911588
Page 109 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-20-2020 15:03:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0911589
Page 110 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-20-2020 15:03:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0911590
Page 111 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Oct-20-2020 15:03:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0911591
Page 112 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Oct-20-2020 15:03:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0911592
Page 113 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Oct-20-2020 15:03:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0911593
Page 114 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Oct-20-2020 15:03:09 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0911594
Page 115 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-11-2021 19:36:58 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-11-2021 15:37:13 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-11-2021 12:01:34 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Mar-11-2021 10:21:38 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Mar-10-2021 14:03:08 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0911595
Page 116 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-04-2021 09:40:01 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-13-2020 15:46:14 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, 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-13-2020 11:12:46 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-26-2020 20:20:44 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-26-2020 13:37:03 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0911596
Page 117 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
N/A
Approved Oct-23-2020 18:22:59 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, 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.
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0911597
Page 118 of 192
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-20-2020 14:09:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-20-2020 14:09:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911598
Page 119 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-20-2020 14:10:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/20/2020Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911599
Page 120 of 192
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-20-2020 14:09:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10471012Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-20-2020 14:09:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1962Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-20-2020 14:10:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-20-2020 14:10:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-20-2020 14:10:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911600
Page 121 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-20-2020 14:11:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911601
Page 122 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-20-2020 14:11:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-20-2020 14:11:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-20-2020 14:11:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911602
Page 123 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-20-2020 14:20:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:hypothyriodism
Start Date: UNK/UNK/20
15
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:20:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:20:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
hypothyriodismInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-20-2020 14:20:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-20-2020 14:20:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-20-2020 14:22:43 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0911603
Page 124 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central Time
(US & Canada)(autocalc) Line/MH Number: 2
Medical History Ter
m:migraines
Start Date: UNK/UNK/20
03
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:22:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:22:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
migrainesInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-20-2020 14:22:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2003Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-20-2020 14:22:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-20-2020 14:35:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number: 3
Medical History T
erm:hysterectomy
Start Date: Dec/UNK/2003Transcription Error
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911604
Page 125 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
Dec/UNK/2
003
Aug-20-2020 14:35:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number: 3
Medical History T
erm:hysterectomy
Start Date: UNK/UNK/200
3
Ongoing: NO
End Date:
Dec/UNK/2
003Transcription Error
Aug-20-2020 14:27:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:hysterectomy
Start Date: UNK/UNK/200
3
Ongoing: NO
End Date:
UNK/UNK/2
003Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911605
Page 126 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:27:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:27:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
hysterectomyInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-20-2020 14:35:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/UNK/2003Transcription Error
Aug-20-2020 14:27:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2003Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-20-2020 14:35:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/UNK/2003Transcription Error
Aug-20-2020 14:27:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2003Initial Entry
1.d
Date Location User Value Reason
Aug-20-2020 14:29:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:dysfunctional gallb
ladderInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911606
Page 127 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/2018
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:29:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:29:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
dysfunctional gallbladderInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-20-2020 14:29:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-20-2020 14:29:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-20-2020 14:30:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:obesity
Start Date: UNK/UNK/19
92
Ongoing: YESInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0911607
Page 128 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:30:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:30:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
obesityInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-20-2020 14:30:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1992Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-20-2020 14:30:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-20-2020 14:31:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:depression
Start Date: UNK/UNK/20
08
Ongoing: YESInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0911608
Page 129 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:31:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:31:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
depressionInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-20-2020 14:31:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-20-2020 14:31:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-20-2020 14:32:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Ter
m:allergy to sulfa
Start Date: UNK/UNK/20
13
Ongoing: YESInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0911609
Page 130 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:32:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:32:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
allergy to sulfaInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-20-2020 14:32:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-20-2020 14:32:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-20-2020 14:34:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Ter
m:cholecystectomy
Start Date: Feb/UNK/2018
Ongoing: NO
End Date:
Feb/UNK/20
18Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0911610
Page 131 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:34:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:34:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cholecystectomyInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-20-2020 14:34:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/UNK/2018Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-20-2020 14:34:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Feb/UNK/2018Initial Entry
1.i
Date Location User Value Reason
Aug-20-2020 14:37:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Ter
m:gastric bypass
Start Date: Jun/UNK/2001
Ongoing: NO
End Date:
Jun/UNK/20
01Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0911611
Page 132 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Aug-20-2020 14:37:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 14:37:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
gastric bypassInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-20-2020 14:37:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/2001Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-20-2020 14:37:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jun/UNK/2001Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0911612
Page 133 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-20-2020 14:19:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-20-2020 14:19:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
237.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-20-2020 14:19:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-20-2020 14:19:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
69.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-20-2020 14:19:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-20-2020 14:19:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
35.1Initial Entry
7.a
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911613
Page 134 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-20-2020 14:19:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.0
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-20-2020 14:19:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-20-2020 14:19:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
98.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-20-2020 14:19:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-20-2020 14:19:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911614
Page 135 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
3. Collection Date:
Date Location User Value Reason
Aug-20-2020 14:17:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Aug-20-2020 14:17:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
Aug-20-2020 14:17:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Define
d Identifier:
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-20-2020 14:17:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-20-2020 14:17:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0911615
Page 136 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-20-2020 14:17:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911616
Page 137 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-20-2020 14:16:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-20-2020 14:16:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
233930Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911617
Page 138 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020 17:02:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020 17:02:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-20-2020 17:02:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-20-2020 17:02:20
(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.
Aug-20-2020 17:02:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-20-2020 17:02:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5XM0Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-20-2020 17:02:33
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry:
BN5XM0Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0911618
Page 139 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
5.b
Date Location User Value Reason
Aug-20-2020 17:02:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5XM1Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-20-2020 17:02:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN5XM1Initial Entry
5.c
Date Location User Value Reason
Aug-20-2020 17:03:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5XM2Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-20-2020 17:03:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BN5XM2Initial Entry
5.d
Date Location User Value Reason
Aug-20-2020 17:03:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLB675Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-20-2020 17:03:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLB675Initial Entry
5.e
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911619
Page 140 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-20-2020 17:03:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLB676Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-20-2020 17:03:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLB676Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911620
Page 141 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020 17:01:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020 17:01:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-20-2020 17:01:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-20-2020 17:01:45
(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.
Aug-20-2020 17:01:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-20-2020 17:01:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5XP0Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-20-2020 17:01:58
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry:
BN5XP0Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0911621
Page 142 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911622
Page 143 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-20-2020 14:12:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-20-2020 14:12:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-20-2020 14:12:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-20-2020 14:12:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/20/2020 12:29Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-20-2020 14:12:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-20-2020 14:12:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0911623
Page 144 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-20-2020 14:12:30
(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
Aug-20-2020 14:12:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-20-2020 14:12:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911624
Page 145 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-20-2020 14:11:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911625
Page 146 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-08-2020 19:56:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911626
Page 147 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020 19:59:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/8/2020Initial Entry
2.a
Date Location User Value Reason
Sep-08-2020 19:59:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.7
Temperature Unit: F
Temperature Location
::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-08-2020 19:59:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-08-2020 19:59:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
97.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-08-2020 19:59:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-08-2020 19:59:21
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911627
Page 148 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911628
Page 149 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-08-2020 19:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-08-2020 19:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-08-2020 19:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-08-2020 19:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-08-2020 19:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-08-2020 19:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defined Ident
ifier:Not Applica
ble
Test:: Not Applica
bleInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911629
Page 150 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Result:: Not Applica
ble
Not Done:: Not Applica
ble
6.a Sponsor ID:
Date Location User Value Reason
Sep-08-2020 19:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-08-2020 19:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-08-2020 19:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-08-2020 19:59:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911630
Page 151 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 19:59:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 19:59:55
(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-09-2020 08:53:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-09-2020 08:53:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/8/2020Transcription Error
Sep-08-2020 22:37:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-08-2020 19:59:55
(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-08-2020 19:59:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
5.a
Date Location User Value Reason
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0911631
Page 152 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-09-2020 08:53:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BJLLS5Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-09-2020 08:53:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BJLLS5Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911632
Page 153 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-08-2020 19:59:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020 19:59:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020 19:59:07
(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-08-2020 19:59:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/8/2020 19:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020 19:59:07
(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-08-2020 19:59:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (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-2021-5683-0911633
Page 154 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-08-2020 19:59:07
(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-08-2020 19:59:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-08-2020 19:59:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0911634
Page 155 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User ValueReason
Oct-28-2020
01:50:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedAs per site confirmation -
updated PD tracker
Oct-27-2020
15:32:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredPatient out of window due to
COVID Visit.
Oct-27-2020
00:23:27
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 13 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately.
Oct-26-2020
13:37:03
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Oct/2
6/202
0Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0911635
Page 156 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-26-2020 15:17:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-26-2020 15:17:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-26-2020 15:17:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-26-2020 15:17:10
(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-26-2020 15:17:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/26/2020Initial Entry
5.a
Date Location User Value Reason
Oct-26-2020 15:17:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPSZ4LInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-26-2020 15:17:22
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry:
BPSZ4LInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911636
Page 157 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
5.b
Date Location User Value Reason
Oct-26-2020 15:17:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPSZ4MInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-26-2020 15:17:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPSZ4MInitial Entry
5.c
Date Location User Value Reason
Oct-26-2020 15:17:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPSZ4NInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-26-2020 15:17:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPSZ4NInitial Entry
5.d
Date Location User Value Reason
Oct-26-2020 15:17:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSHNX5Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-26-2020 15:17:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BSHNX5Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911637
Page 158 of 192
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-11-2021 10:21:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/11/2021Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911638
Page 159 of 192
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-11-2021 10:21:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-11-2021 10:21:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-11-2021 10:22:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-11-2021 10:21:50
(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.
Mar-11-2021 10:21:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/11/2021Initial Entry
5.a
Date Location User Value Reason
Mar-11-2021 10:22:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRJ2NMInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-11-2021 10:22:02
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry:
BRJ2NMInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0911639
Page 160 of 192
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
5.b
Date Location User Value Reason
Mar-11-2021 10:22:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRJ2NNInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-11-2021 10:22:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BRJ2NNInitial Entry
5.c
Date Location User Value Reason
Mar-11-2021 10:22:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRJ2NPInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-11-2021 10:22:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BRJ2NPInitial Entry
5.d
Date Location User Value Reason
Mar-11-2021 10:22:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLB6VCInitial Entry
5.d Sample ID
Date Location User Value Reason
Mar-11-2021 10:22:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BLB6VCInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911640
Page 161 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-21-2020 07:10:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Oct-20-2020 15:04:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Answered completed
Oct-19-2020 15:11:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Erica Weaver Query 3: Opened Please enter the
Healthcare Utilization
and Microbilogy
specimen forms.
Oct-15-2020 10:16:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 10:13:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-15-2020 10:12:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date of
Assessment in the
Signs and Symptoms
form is missing.
Please review and
update as appropriate.
Oct-15-2020 10:12:43
(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.
Oct-15-2020 10:12:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0911641
Page 162 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-15-2020 10:12:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911642
Page 163 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: 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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-15-2020 10:13:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-15-2020 10:13:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Oct-15-2020 10:13:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolved:
Oct/14/2020Initial Entry
4.a
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911643
Page 164 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: 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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASE
D COUGH
Symptom Pr
esent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Oct-15-2020 10:13:09
(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
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREASED S
HORTNESS OF BREATH
Symptom
Present:NOInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911644
Page 165 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: 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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.c Symptoms:
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORTNESS
OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASED
MUSCLE PAINInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911645
Page 166 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: 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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Symptom P
resent:NO
4.e Symptoms:
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCLE PA
INInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW LOSS OF TASTE
OR SMELL
Symptom P
resent:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911646
Page 167 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: 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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREASED
SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE THRO
ATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present: YESInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911647
Page 168 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: 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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.h Symptoms:
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.i
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-15-2020 10:13:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911648
Page 169 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-20-2020 15:03:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-20-2020 15:03:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-20-2020 15:03:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-20-2020 15:03:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Oct-20-2020 15:03:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911649
Page 170 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-20-2020 15:03:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7. Test Result:
Date Location User Value Reason
Oct-20-2020 15:03:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Oct-20-2020 15:03:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Oct-20-2020 15:03:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911650
Page 171 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: 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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 10:14:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 10:14:04
(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
Oct-16-2020 08:00:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-16-2020 05:56:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-15-2020 10:16:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-15-2020 10:16:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-15-2020 10:16:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/12/2020Transcription Error
Oct-15-2020 10:14:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Sample Collected?' is
marked as No and 'If
no sample was
collected or sample
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911651
Page 172 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: 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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
was not collected
according to protocol,
please provide reason'
is missing. Please
review and update as
appropriate.
Oct-15-2020 10:14:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Oct-16-2020 08:00:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: CV16937Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 08:00:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CV16937Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911652
Page 173 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 10:15:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 10:15:27
(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-15-2020 10:15:27
(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
Oct-15-2020 10:15:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
no office visitInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911653
Page 174 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Oct-20-2020 15:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIAL
IST
Occurrence of Visits or
Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-20-2020 15:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-20-2020 15:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-20-2020 15:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: EMERGENC
Y ROOM
Occurrence of Visits
or Contacts:NOInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911654
Page 175 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-20-2020 15:01:44
(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
Oct-20-2020 15:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Oct-20-2020 15:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practition
er:PRIMARY CAR
E PHYSICIAN
Occurrence of Vis
its or Contacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-20-2020 15:01:44
(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
Oct-20-2020 15:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Oct-20-2020 15:01:44
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0911655
Page 176 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) Type of Practitioner: URGENT C
ARE
Occurrence of Visits or
Contacts:NO
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-20-2020 15:01:44
(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
Oct-20-2020 15:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-20-2020 15:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practition
er:TELEPHONE C
ONSULTATION
Occurrence of Vis
its or Contacts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-20-2020 15:01:44
(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
Oct-20-2020 15:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911656
Page 177 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f
Date Location User Value Reason
Oct-20-2020 15:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or Con
tacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-20-2020 15:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-20-2020 15:01:44
(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
Oct-20-2020 15:01:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911657
Page 178 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/12/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Oct-15-2020 10:16:26
(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
Oct-15-2020 10:16:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-15-2020 10:16:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911658
Page 179 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/13/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-13-2020 11:12:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/13/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-13-2020 11:12:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911659
Page 180 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/13/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-13-2020 14:12:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020 14:12:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020 14:12:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-13-2020 14:12:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Nov-13-2020 14:12:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/13/2020Initial Entry
5.a
Date Location User Value Reason
Nov-13-2020 14:12:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPSXXFInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-13-2020 14:12:11
(UTC-06:00) Central TimeACV0PFEINFP6000 Data Entry:
BPSXXFInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0911660
Page 181 of 192
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/13/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
5.b
Date Location User Value Reason
Nov-13-2020 14:12:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPSXXGInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-13-2020 14:12:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPSXXGInitial Entry
5.c
Date Location User Value Reason
Nov-13-2020 14:12:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPSXXHInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-13-2020 14:12:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPSXXHInitial Entry
5.d
Date Location User Value Reason
Nov-13-2020 14:12:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSHP4NInitial Entry
5.d Sample ID
Date Location User Value Reason
Nov-13-2020 14:12:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BSHP4NInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911661
Page 182 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-26-2020 13:37:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-26-2020 13:37:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-26-2020 13:37:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911662
Page 183 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-11-2021 15:37:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911663
Page 184 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-11-2021 15:37:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-11-2021 15:37:13
(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
Mar-11-2021 15:37:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Syncope episodesInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-11-2021 15:37:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/19/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 15:37:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Feb/21/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-11-2021 15:37:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0911664
Page 185 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-11-2021 15:37:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Syncope
episodes: Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Mar-11-2021 15:37:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated with c
ongenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prol
ong hospitalization?
YES
Did this serious event result in persist
ent or significant disability/incapacit
y?
NO
Is this serious event life threatening?
NO
Other medically important serious ev
ent
NOInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0911665
Page 186 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-11-2021 15:37:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-11-2021 15:37:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
StressInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-11-2021 15:37:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-11-2021 15:37:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-11-2021 15:37:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911666
Page 187 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Mar-11-2021 15:37:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-11-2021 15:37:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b)
(6)
(b)
(4),
(b)
(6)
FDA-CBER-2021-5683-0911667
Page 188 of 192
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-04-2021 09:40:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/2/2021Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911668
Page 189 of 192
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-04-2021 09:40:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-04-2021 09:40:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response indicates
participant was
unblinded, however
the TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Feb-04-2021 09:40:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for Va
ccination 3
Participant is:
eligible and NOT confirmed to ha
ve received only placebo at Vacci
nation 1/2Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911669
Page 190 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-04-2021 09:40:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/2/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-04-2021 09:40:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR ADDIT
IONAL VACCINATIONInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911670
Page 191 of 192
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-26-2020 13:37:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-20-2020 14:16:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-20-2020 14:11:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-26-2020 13:37:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/26/2020Initial Entry
Aug-20-2020 14:16:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/20/2020Initial Entry
Aug-20-2020 14:11:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/20/2020Initial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
FDA-CBER-2021-5683-0911671
Page 192 of 192
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471012 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-23-2020 18:22:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae307f\Final\Final On: 01-Apr-2021 04:07 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0911672