Document text
Page 1 of 141
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987659
Page 2 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/21/2020
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987660
Page 3 of 141
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11421247]
2.Birth Date: /1948
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:
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987661
Page 4 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987662
Page 5 of 141
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987663
Page 6 of 141
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987664
Page 7 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergy to penicillin]
Start Date: UNK/UNK/1970
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[breast cancer]
Start Date: UNK/UNK/1992
Ongoing: NO
End Date:
UNK/UNK/1992
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[(R) mastectomy]
Start Date: UNK/UNK/1992
Ongoing: NO
End Date:
UNK/UNK/1992
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987665
Page 8 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[(R) breast reconstruction]
Start Date: UNK/UNK/1992
Ongoing: NO
End Date:
UNK/UNK/1992
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Atrioventricular block, complete]
Start Date: UNK/UNK/1996
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Paroxysmal Atrial Fibrillation]
Start Date: Apr/8/2015
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sinoatrial Node Dysfunction]
Start Date: Jun/27/2012
Ongoing: YES
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987666
Page 9 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Paroxysmal supraventricular tachycardia]
Start Date: May/11/2015
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cardiac pacemaker in situ]
Start Date: UNK/UNK/1996
Ongoing: YES
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987667
Page 10 of 141
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/21/2020
2.Weight: [132.2]
3.Unit: LB
4.Height: [65.0]
5.Unit: in
6.Body Mass Index: [22.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987668
Page 11 of 141
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/21/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987669
Page 12 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/21/2020
2.Randomization Number: [261686]
3.Randomization Group: [ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987670
Page 13 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/21/2020
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 [BP9V5D]
5.bSample ID [BNWT42]
5.cSample ID [BNWT43]
5.dSample ID [BNWT44]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987671
Page 14 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/21/2020
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 [BP9V3F]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987672
Page 15 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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/21/2020 10:03
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
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987673
Page 16 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987674
Page 17 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987675
Page 18 of 141
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987676
Page 19 of 141
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/14/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987677
Page 20 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR91K2]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987678
Page 21 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: Oct/14/2020 15:16
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
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987679
Page 22 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/16/2020
2.Erroneous Visit
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987680
Page 23 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/16/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCCMT]
5.bSample ID [BRCCMV]
5.cSample ID [BLGBSP]
5.dSample ID [BSMCV4]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987681
Page 24 of 141
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987682
Page 25 of 141
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987683
Page 26 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987684
Page 27 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987685
Page 28 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987686
Page 29 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987687
Page 30 of 141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987688
Page 31 of 141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987689
Page 32 of 141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987690
Page 33 of 141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987691
Page 34 of 141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987692
Page 35 of 141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987693
Page 36 of 141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987694
Page 37 of 141
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987695
Page 38 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987696
Page 39 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987697
Page 40 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987698
Page 41 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987699
Page 42 of 141
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Ventricular arrhy
thmias Oct/14/2020 UN
K:UNK NO
End Date Time:
Oct/21/2020 UNK:UN
K
Repeating
Pages
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987700
Page 43 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[Ventricular arrhythmias]
4.Start Date Time: Oct/14/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/21/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987701
Page 44 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
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[2020412397]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987702
Page 45 of 141
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
1. Repeating
Pages
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987703
Page 46 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987704
Page 47 of 141
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987705
Page 48 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: //
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987706
Page 49 of 141
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987707
Page 50 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987708
Page 51 of 141
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
1. Repeating
Pages
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987709
Page 52 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987710
Page 53 of 141
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987711
Page 54 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987712
Page 55 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987713
Page 56 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987714
Page 57 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987715
Page 58 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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:
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987716
Page 59 of 141
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987717
Page 60 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987718
Page 61 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987719
Page 62 of 141
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987720
Page 63 of 141
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987721
Page 64 of 141
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987722
Page 65 of 141
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987723
Page 66 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987724
Page 67 of 141
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987725
Page 68 of 141
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987726
Page 69 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Oct/27/2020
2.Primary Reason for Unblinding: SUBJECT SAFETY CONCERN
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987727
Page 70 of 141
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987728
Page 71 of 141
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987729
Page 72 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/16/2020
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987730
Page 73 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987731
Page 74 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Richard Rupp Approved Nov-17-2020 15:44:52 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardRupp, 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.
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987732
Page 75 of 141
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-21-2020 14:02:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987733
Page 76 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Richard Rupp Approved Nov-17-2020 15:44:52 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardRupp, 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-17-2020 13:40:08 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Rupp Approved Nov-12-2020 14:47:52 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardRupp, 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.
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987734
Page 77 of 141
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-21-2020 14:01:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-21-2020 14:01:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987735
Page 78 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-21-2020 14:01:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Sep/21/2020Initial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987736
Page 79 of 141
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-21-2020 14:01:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11421247Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-21-2020 14:01:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1948Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-21-2020 14:02:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-21-2020 14:02:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO
(A) OR OF SPANISH ORIGI
NInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-21-2020 14:02:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987737
Page 80 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-21-2020 14:02:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987738
Page 81 of 141
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-21-2020 14:02:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-21-2020 14:02:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-21-2020 14:02:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987739
Page 82 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Sep-21-2020 14:03:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:allergy to pen
icillin
Start Date: UNK/UNK/1
970
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-21-2020 14:03:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-21-2020 14:03:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
allergy to penicillinInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-21-2020 14:03:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1970Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-21-2020 14:03:07 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987740
Page 83 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-06:00) Central
Time (US & Canada)YES
1.b
Date Location User Value Reason
Sep-21-2020 14:03:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:breast cancer
Start Date: UNK/UNK/19
92
Ongoing: NO
End Date:
UNK/UNK
/1992Initial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0987741
Page 84 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-21-2020 14:03:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-21-2020 14:03:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
breast cancerInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-21-2020 14:03:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1992Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-21-2020 14:03:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1992Initial Entry
1.c
Date Location User Value Reason
Sep-22-2020 09:39:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:(R) mastecto
my
Start Date: UNK/UNK/1
992separating
mastectomy &
reconstruction
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987742
Page 85 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Ongoing: NO
End Date:
UNK/UN
K/1992
Sep-21-2020 14:05:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:(R) mastectomy
& reconstruction
Start Date
:UNK/UNK/199
2
Ongoing: NO
End Date:
UNK/UNK/1
992Initial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987743
Page 86 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.c Line/MH Number:
Date Location User Value Reason
Sep-21-2020 14:05:59
(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 ValueReason
Sep-22-2020
10:39:16
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clo
sedDiscrepancy has been
closed.
Sep-22-2020
09:39:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dseparating mastectomy
& reconstruction
Sep-22-2020
09:39:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
(R) m
astect
omyseparating mastectomy
& reconstruction
Sep-21-2020
17:28:04
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedMultiple concepts in
the term (R)
MASTECTOMY &
RECONSTRUCTION.
Split the term into (R)
MASTECTOMY and
BREAST
RECONSTRUCTION
and submit separately.
Thank you.
Sep-21-2020
14:05:59ACV0PFEINFP6000 Data
EntryInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987744
Page 87 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-06:00)
Central Time
(US &
Canada):
(R) m
astect
omy
& rec
onstru
ction
1.c Start Date:
Date Location User Value Reason
Sep-21-2020 14:05:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1992Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-21-2020 14:05:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1992Initial Entry
1.d
Date Location User Value Reason
Sep-22-2020 09:40:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Histo
ry Term:(R) breast recon
struction
Start Date: UNK/UNK/199
2
Ongoing: NO
End Date:
UNK/UNK/
1992Initial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987745
Page 88 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.d Line/MH Number:
Date Location User Value Reason
Sep-22-2020 09:40:31
(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
Nov-02-2020 11:58:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Thank you.
Oct-30-2020 18:31:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Oct-29-2020 08:14:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:Opened Med Hx has been
Unfrozen, Thank
you.
Oct-27-2020 18:14:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Unable to update -
frozen
Oct-26-2020 10:03:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Participant is
noted to have a
pacemaker, the
medical history in
either database
does not reflect
her cardiac
history. Please
update both the
med hx in both the
CRF and in the
FU SAE form.
Sep-22-2020 09:40:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
(R) breast reconstructionInitial Entry
1.d Start Date:
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987746
Page 89 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Sep-22-2020 09:40:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1992Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-22-2020 09:40:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1992Initial Entry
1.e
Date Location User Value Reason
Oct-30-2020 18:29:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Hist
ory Term:Atrioventricular
block, complete
Start Date: UNK/UNK/1996
Ongoing: YESInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987747
Page 90 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.e Line/MH Number:
Date Location User Value Reason
Oct-30-2020 18:29:38
(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
Oct-30-2020 18:29:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Atrioventricular block, comple
teInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-30-2020 18:29:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1996Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-30-2020 18:29:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-30-2020 18:30:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:Paroxysmal Atri
al Fibrillation
Start Date: Apr/8/2015
Ongoing: YESInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987748
Page 91 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.f Line/MH Number:
Date Location User Value Reason
Oct-30-2020 18:30:09
(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
Oct-30-2020 18:30:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Paroxysmal Atrial FibrillationInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-30-2020 18:30:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/8/2015Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-30-2020 18:30:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Oct-30-2020 18:30:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Hist
ory Term:Sinoatrial Node
Dysfunction
Start Date: Jun/27/2012
Ongoing: YESInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987749
Page 92 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.g Line/MH Number:
Date Location User Value Reason
Oct-30-2020 18:30:35
(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
Oct-30-2020 18:30:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sinoatrial Node DysfunctionInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-30-2020 18:30:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/27/2012Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-30-2020 18:30:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Oct-30-2020 18:31:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical Hi
story Term
:Paroxysmal suprav
entricular tachycar
dia
Start Date: May/11/2015
Ongoing: YESInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987750
Page 93 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.h Line/MH Number:
Date Location User Value Reason
Oct-30-2020 18:31:04
(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
Oct-30-2020 18:31:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Paroxysmal supraventricular ta
chycardiaInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-30-2020 18:31:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
May/11/2015Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-30-2020 18:31:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987751
Page 94 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.i
Date Location User Value Reason
Oct-30-2020 18:31:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:9
Medical Histo
ry Term:Cardiac pacem
aker in situ
Start Date: UNK/UNK/19
96
Ongoing: YESInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987752
Page 95 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.i Line/MH Number:
Date Location User Value Reason
Oct-30-2020 18:31:37
(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
Oct-30-2020 18:31:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cardiac pacemaker in situInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-30-2020 18:31:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1996Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-30-2020 18:31:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987753
Page 96 of 141
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-21-2020 14:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-21-2020 14:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
132.2Initial Entry
3. Unit:
Date Location User Value Reason
Sep-21-2020 14:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-21-2020 14:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
65.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-21-2020 14:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0987754
Page 97 of 141
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-21-2020 14:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22.0Initial Entry
7.a
Date Location User Value Reason
Sep-21-2020 14:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 97.6
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-21-2020 14:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-21-2020 14:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-21-2020 14:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987755
Page 98 of 141
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-21-2020 14:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987756
Page 99 of 141
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-21-2020 14:09:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-21-2020 14:09:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-21-2020 14:09:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-21-2020 14:09:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-21-2020 14:09:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987757
Page 100 of 141
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Sep-21-2020 14:09:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-21-2020 14:09:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-21-2020 14:09:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-21-2020 14:09:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987758
Page 101 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-21-2020 14:09:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-21-2020 16:31:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
261686Initial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987759
Page 102 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020 14:09:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020 14:09:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-21-2020 16:23:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-21-2020 14:09:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-21-2020 14:09:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/21/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987760
Page 103 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-21-2020 16:23:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9V5DInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-21-2020 16:23:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9V5DInitial Entry
5.b
Date Location User Value Reason
Sep-21-2020 16:48:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWT42Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-21-2020 16:48:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNWT42Initial Entry
5.c
Date Location User Value Reason
Sep-21-2020 16:48:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWT43Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-21-2020 16:48:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNWT43Initial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0987761
Page 104 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d
Date Location User Value Reason
Sep-21-2020 16:48:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWT44Initial Entry
5.d Sample ID
Date Location User Value Reason
Sep-21-2020 16:48:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNWT44Initial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987762
Page 105 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020 14:09:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020 14:09:34
(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-21-2020 16:22:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-21-2020 14:09:34
(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-21-2020 14:09:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/21/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987763
Page 106 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-21-2020 16:22:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9V3FInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-21-2020 16:22:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9V3FInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987764
Page 107 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-21-2020 14:09:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-21-2020 14:09:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-21-2020 14:09:53
(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-21-2020 14:09:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020 10:03Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-21-2020 14:09:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987765
Page 108 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-21-2020 14:09:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-21-2020 14:09:53
(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-21-2020 14:09:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-21-2020 14:09:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987766
Page 109 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-21-2020 14:09:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987767
Page 110 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020 15:52:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987768
Page 111 of 141
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-14-2020 15:53:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
2.a
Date Location User Value Reason
Oct-14-2020 15:53:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 98.4
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-14-2020 15:53:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-14-2020 15:53:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-14-2020 15:53:00 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0987769
Page 112 of 141
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-06:00) Central
Time (US & Canada)F
2.a Temperature Location:
Date Location User Value Reason
Oct-14-2020 15:53:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0987770
Page 113 of 141
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-14-2020 15:53:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-14-2020 15:53:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-14-2020 15:53:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-14-2020 15:53:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-14-2020 15:53:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987771
Page 114 of 141
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Oct-14-2020 15:53:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-14-2020 15:53:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-14-2020 15:53:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-14-2020 15:53:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987772
Page 115 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020 15:53:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020 15:53:20
(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 18:47:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-15-2020 03:33:14
(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.
Oct-14-2020 15:53:20
(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.
Oct-14-2020 15:53:20
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987773
Page 116 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada) Date of Collection:
Oct/14/2020
5.a
Date Location User Value Reason
Oct-15-2020 18:47:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR91K2Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 18:47:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR91K2Initial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987774
Page 117 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-14-2020 15:53:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-14-2020 15:53:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-14-2020 15:53:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-14-2020 15:53:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020 15:16Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-14-2020 15:53:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987775
Page 118 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-14-2020 15:53:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-14-2020 15:53:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-14-2020 15:53:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-14-2020 15:53:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987776
Page 119 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-17-2020 14:12:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/16/2020Initial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987777
Page 120 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-17-2020 13:40:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-17-2020 13:40:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-17-2020 13:45:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-17-2020 13:40:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-17-2020 13:40:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/16/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987778
Page 121 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-17-2020 13:45:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRCCMTInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-17-2020 13:45:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRCCMTInitial Entry
5.b
Date Location User Value Reason
Nov-17-2020 13:45:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRCCMVInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-17-2020 13:45:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRCCMVInitial Entry
5.c
Date Location User Value Reason
Nov-17-2020 13:45:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLGBSPInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-17-2020 13:45:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLGBSPInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0987779
Page 122 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d
Date Location User Value Reason
Nov-17-2020 13:46:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSMCV4Initial Entry
5.d Sample ID
Date Location User Value Reason
Nov-17-2020 13:46:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSMCV4Initial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987780
Page 123 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Oct-22-2020 15:39:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987781
Page 124 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-22-2020 15:39:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-22-2020 15:39:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-11-2020 06:06:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 3: Closed Response satisfies
query
Nov-09-2020 16:57:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Updated report with
additional
information was
submitted last week.
Nov-09-2020 12:23:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 3: Reissued:Opened Appreciate that this
is not in the medical
record but email
sent from Lead
Safety MM to the
site/PI to kindly
speak directly to the
cardiologist as was
done during the
initial reported to
clarify/confirm.
Please provide an
update on the status.
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987782
Page 125 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-04-2020 16:35:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Data is not in
subject's medical
record. Cardiologist
notes do not contain
this information.
Nov-04-2020 13:33:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 3: Opened Kindly submit a FU
SAE to
describe/clarify rate,
duration and QRS
characteristics of
VT episodes based
on cardiologist
assessment in order
to confirm current
diagnosis of VT
(rather than the
participant’s report).
Nov-02-2020 15:30:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Closed Appreciate the
response. Thank
you!
Oct-30-2020 18:48:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered SAE reported
exactly as subject
reported it. F/U
SAE report was just
sent with results of
EP study.
Oct-30-2020 16:41:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 2: Opened Clinical_ In the
SAE narrative,
episodes of 2 and 4
heart beats are
reported. VT
definition = >3
heartbeats of
ventricular origin at
a rate > 100/min
(QRS >120
millisec) < 30sec.
Please submit a FU
SAE to
describe/clarify rate,
duration and QRS.
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987783
Page 126 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-28-2020 09:55:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Thank you
Oct-27-2020 18:22:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Previous report
includes all blood
work ordered by
cardiologist, EP
study scheduled for
29Oct2020. No
updates at this time.
Oct-26-2020 10:23:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Per case narrative,
participant was
evaluated by
cardiologist. Please
submit in the FU
SAE report the
cardiologist
assessment: rhythm
and timing of the
events recorded,
specify blood work
performed/results,
timing of EP study
and additional
workup.
Oct-22-2020 15:39:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Ventricular arrhythmiasInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-03-2020
06:58:52 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Nov-02-2020 11:21:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Updated form
already sent
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987784
Page 127 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-01-2020
07:33:01 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened SAE RECON 2:
The onset date was
still recorded as
16OCT2020 in
Safety listing. Per
narrative of the case
'Event with onset
date 16Oct2020.' If
the correct onset
date is 14Oct2020
please submit a
follow-up SAE form
to update SDB.
Oct-31-2020 09:39:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Candidat
eSAE RECON:
Pending SDB
update.
Oct-31-2020 05:55:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Oct-31-2020 02:59:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 5: Closed Response satisfies
query
Oct-30-2020 08:48:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 5: Answered Changed data per
query
Oct-30-2020 08:46:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Updated report
submitted yesterday.
Oct-30-2020 08:45:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered Started after
vaccination.
Oct-29-2020 13:14:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 3: Closed Thank you.
Oct-29-2020 08:41:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Reissued:Opened DM: Thanks for
response. Please
consider to provide
the best estimated
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987785
Page 128 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
time of the event,
else confirm if the
event started before
or after vaccination.
Thank you.
Oct-29-2020 04:24:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened SAE RECON 2: Per
latest SAE listing
onset date is still
recorded as
16Oct2020. If the
correct onset date is
14Oct2020 as
recorded in AE
CRF. Please submit
a follow up AEM
form to correct
onset date in Safety.
Oct-29-2020 00:50:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
PuigQuery 5: Opened IVRS
Reconciliation:
BLIND BROKEN?
in IMPALA is YES
but TREATMENT
UNBLINDED form
has not been
completed in
InForm. Please
review and update
as appropriate. Else,
clarify. Thank you.
Oct-28-2020 17:45:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered Exact time
unknown. Evening.
Oct-28-2020 17:45:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Opened For AE Ventricular
arrhythmias: Start
Date is the same as
a Vaccination Date,
but time is not
provided. Please
review and update
as appropriate.
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987786
Page 129 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-28-2020 17:45:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Event was reported
in evening. More
precise time not
known.
Oct-28-2020 17:45:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Event was reported
in evening. More
precise time not
known.
Oct-28-2020 17:45:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020 UNK:UNKEvent was reported
in evening. More
precise time not
known.
Oct-28-2020 15:09:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 3: Reissued:Opened The onset time
recorded here is
15:46, however in
cases narrative
reflects the
EVENING. Please
re-assess and
confirm which one
is the correct onset
time. Thank you.
Oct-27-2020 21:54:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened SAE RECON 1: If
the correct onset
date is 14Oct2020.
Please confirm if a
follow up AEM
form was submitted
to update onset date
in Safety database.
Oct-27-2020 18:00:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Initiated 14Oct2020,
first reported
16Oct2020.
Oct-26-2020 17:42:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Time is unknown.
Oct-26-2020 10:05:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 3: Opened Clinical_AE is
noted to be within
30 minutes of Vax 2,
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987787
Page 130 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
which differs from
the narrative which
is noted to occur
that evening. Please
clarify the onset
timing on CRF and
with a FU SAE
report.
Oct-25-2020 07:41:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE RECON:
AER#2020412397
Oct-22-2020 15:40:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-22-2020 15:40:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020 15:46Query resolution
Oct-22-2020 15:39:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Ventricular
arrhythmias: Start
Date is the same as
a Vaccination Date,
but time is not
provided. Please
review and update
as appropriate.
Oct-22-2020 15:39:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/14/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-09-2020 17:00:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/21/2020 UNK:UNKNew Information
Oct-22-2020 15:39:43
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0987788
Page 131 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
6. Toxicity Grade:
Date Location User Value Reason
Oct-27-2020 22:12:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Oct-27-2020 18:03:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Oct-27-2020 18:03:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Changed
Information
Oct-26-2020 10:08:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Please confirm
that, per protocol
definition of life
threatening, this
event has the
appropriate
toxicity grading.
Oct-22-2020 15:39:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-24-2020 09:00:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Deleted Close Auto Query
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987789
Page 132 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-24-2020 08:58:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Oct-23-2020 17:56:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Candidate For AE Ventricular
arrhythmias:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-23-2020 17:56:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associ
ated with congenital anom
aly or birth defect?
NO
Did this serious event resu
lt in death?
NO
Did this serious event requ
ire or prolong hospitalizati
on?
NO
Did this serious event resuNew Information
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987790
Page 133 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
lt in persistent or significa
nt disability/incapacity?
NO
Is this serious event life th
reatening?
NO
Other medically important
serious event
YES
Oct-23-2020 17:56:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Already reported
Oct-23-2020 06:32:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE
RECON:Ventricular
arrhythmias(Onset
date:14Oct2020) is
not reported to
Safety database but
marked serious on
AE CRF. Confirm
seriousness and
report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Oct-23-2020 06:31:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted Query can be
addressed internally
Oct-22-2020 15:39:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Ventricular
arrhythmias:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987791
Page 134 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
blank.
Oct-22-2020 15:39:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associ
ated with congenital anom
aly or birth defect?
NO
Did this serious event resu
lt in death?
NO
Did this serious event requ
ire or prolong hospitalizati
on?
NO
Did this serious event resu
lt in persistent or significa
nt disability/incapacity?
NO
Is this serious event life th
reatening?
YES
Other medically important
serious event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-22-2020 15:39:43
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987792
Page 135 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-22-2020 15:39:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-22-2020 15:39:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-22-2020 15:39:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-22-2020 15:39:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-10-2020
02:24:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Closed entered at field 5 Is the adverse
event still ongoing?
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (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-2021-5683-0987793
Page 136 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-09-2020
17:00:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 2: Answered There is no place to enter end
date/time
Nov-09-2020
06:29:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sandip
Namdeorao
SuryawanshiQuery 2: Opened Outcome is
“RECOVERED/RESOLVED”,
but end date/time is missing.
Please verify and update as
appropriate. Else clarify
Nov-05-2020
01:19:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Nov-04-2020
16:35:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Nov-04-2020
16:35:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RES
OLVEDNew Information
Nov-04-2020
01:02:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020412397
outcome was updated to
RECOVERED/RESOLVED
on Safety database while
reported as Not Recovered/Not
Resolved in AE CRF. Please
confirm correct outcome. If
safety update is required,
please submit a follow-up
form.
Oct-22-2020
15:39:43
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
NOT RECOVERE
D/NOT RESOLVEInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987794
Page 137 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Central Time (US
& Canada)D
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-22-2020 15:39:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-24-2020 09:00:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020412397Initial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987795
Page 138 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-17-2020 14:12:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-17-2020 14:12:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-17-2020 14:12:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987796
Page 139 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Nov-03-2020 01:46:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Data updated.
Nov-02-2020 11:27:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Nov-02-2020 11:27:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/27/2020New Information
Nov-02-2020 07:06:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Katherine
PuigQuery 1: Opened IVRS
Reconciliation:
Date of BLIND
BROKEN in
IMPALA is
(27-OCT-2020) but
DATE
TREATMENT
UNBLINDED in
InForm is
(28-OCT_2020).
Please review and
update as
appropriate. Else,
clarify. Thank you.
Oct-29-2020 15:55:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/28/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Oct-29-2020 15:55:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SUBJECT SAFETY CONCE
RNInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987797
Page 140 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-17-2020 14:12:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-21-2020 14:09:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-21-2020 14:02:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-17-2020 14:12:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/16/2020Initial Entry
Sep-21-2020 14:09:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/21/2020Initial Entry
Sep-21-2020 14:02:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/21/2020Initial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987798
Page 141 of 141
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421247 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-12-2020 13:58:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e2e\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987799