Document text
Page 1 of 156
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961622
Page 2 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/28/2020
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961623
Page 3 of 156
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10841317]
2.Birth Date: /1989
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961624
Page 4 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961625
Page 5 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use only) IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use only) IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for inclusion
in the study
Criterion met? YES
Criterion ID: (For Pfizer use only) IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance
with the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use only) IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961626
Page 6 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterion met? NO
Criterion ID: (For Pfizer use only) EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use only) EX08A00
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would, in
the opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use only) EX10A00
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961627
Page 7 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing
lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use only) EX16A01
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961628
Page 8 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members
Criterion met? NO
Criterion ID: (For Pfizer use only) EX21A01
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961629
Page 9 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961630
Page 10 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[penicillin allergy]
Start Date: UNK/UNK/1995
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hernia repair]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[inflammation]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hernia]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961631
Page 11 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [94.0]
3.Unit: kg
4.Height: [178.6]
5.Unit: cm
6.Body Mass Index: [29.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961632
Page 12 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [72478]
3.Randomization Group: [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961633
Page 13 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BKMZDG]
5.bSample ID [BKMZDH]
5.cSample ID [BKMZDJ]
5.dSample ID [BPFSW6]
5.eSample ID [BPFSW7]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961634
Page 14 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BPY9HS]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961635
Page 15 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/28/2020 13:47
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
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961636
Page 16 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961637
Page 17 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961638
Page 18 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961639
Page 19 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM5YK0]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961640
Page 20 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/25/2020 09:24
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
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961641
Page 21 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961642
Page 22 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/26/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNX56K]
5.bSample ID [BNX56L]
5.cSample ID [BR031M]
5.dSample ID [BR031N]
5.eSample ID [BR031P]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961643
Page 23 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961644
Page 24 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961645
Page 25 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961646
Page 26 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961647
Page 27 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961648
Page 28 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961649
Page 29 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961650
Page 30 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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: [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961651
Page 31 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961652
Page 32 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961653
Page 33 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961654
Page 34 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961655
Page 35 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961656
Page 36 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961657
Page 37 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/12/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961658
Page 38 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/12/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961659
Page 39 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/12/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Oct/12/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961660
Page 40 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Oct/26/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961661
Page 41 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961662
Page 42 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961663
Page 43 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961664
Page 44 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 Cellulitis in Left
leg Sep/8/2020 UNK:
UNK NO
End Date Time:
Sep/16/2020 UNK:UNK
Repeating
Pages
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961665
Page 45 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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)[Cellulitis in Left leg]
4.Start Date Time: Sep/8/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/16/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961666
Page 46 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[BACTERIAL INFECTION]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
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[2020371862]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961667
Page 47 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961668
Page 48 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961669
Page 49 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961670
Page 50 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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: //
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961671
Page 51 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961672
Page 52 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961673
Page 53 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961674
Page 54 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961675
Page 55 of 156
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961676
Page 56 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961677
Page 57 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961678
Page 58 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961679
Page 59 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961680
Page 60 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961681
Page 61 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961682
Page 62 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961683
Page 63 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961684
Page 64 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961685
Page 65 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961686
Page 66 of 156
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961687
Page 67 of 156
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961688
Page 68 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961689
Page 69 of 156
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961690
Page 70 of 156
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961691
Page 71 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/26/2020
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961692
Page 72 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961693
Page 73 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961694
Page 74 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Feb-03-2021 10:23:51 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-22-2021 18:06:00 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-21-2021 12:07:35 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-11-2020 13:08:52 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961695
Page 75 of 156
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-28-2020 16:11:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-28-2020 16:11:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961696
Page 76 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020 16:11:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/28/2020Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961697
Page 77 of 156
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-29-2020 05:32:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed event recorded in AE CRF
Sep-25-2020 06:13:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020371862
left leg cellulitis(onset
date:08Sep2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Aug-28-2020 16:11:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10841317Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-01-2020 06:58:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed SDB updated. issue
resolved
Sep-30-2020 05:14:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened SAE RECON 1: Per latest
SAE listing, the date of
birth was still blank. Please
submit a follow up AEM
form for AER 2020371862
to provide the correct date
of birth.
Sep-29-2020 16:22:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered This date of birth is correct
Sep-29-2020 05:35:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020371862
,the date of birth was
missing in Safety database
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961698
Page 78 of 156
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
but was recorded as
/1989 in AE CRF.
Please confirm if date of
birth was reported. If safety
update is required, please
submit a follow-up form.
Aug-28-2020 16:10:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1989Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-01-2020 06:58:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed SDB updated. issue
resolved
Sep-30-2020 05:15:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened SAE RECON 1: Per latest
SAE listing, the gender was
still blank. Please submit a
follow up AEM form for
AER 2020371862 to
provide the correct gender.
Sep-29-2020 16:21:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject is male
Sep-29-2020 05:34:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020371862
,the gender was missing in
Safety database but was
recorded as MALE in AE
CRF. Please confirm
gender. If safety update is
required, please submit a
follow-up form.
Aug-28-2020
16:12:02 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(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-2021-5683-0961699
Page 79 of 156
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-28-2020 16:12:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020 16:12:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961700
Page 80 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020 02:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Per site
confirmation-no
COVID illness visit
per PI
Oct-05-2020 14:49:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered no COVID illness
visit per PI
Oct-03-2020 02:46:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened As per Illness ediary
records, subject
reported "Yes" for
the question "Have
you experienced any
of the following?”
for the COVID-19
symptoms or
diagnosis on
20SEP2020. But
there is no COVID
Illness visit reported
in the database.
Please clarify.
Aug-28-2020 16:12:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961701
Page 81 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:1
Crite
rion
Descr
iption
:Male or female participa
nts between the ages of
18 and 55 years, inclusi
ve, 65 and 85 years, incl
usive, or 18 and 85 year
s, inclusive, at randomiz
ation (dependent upon st
udy stage)
Crite
rion
met?:YES
Crite
rion I
D: (F
or Pfi
zer us
e only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Male or female participants bet
ween the ages of 18 and 55 year
s, inclusive, 65 and 85 years, incInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961702
Page 82 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
lusive, or 18 and 85 years, inclu
sive, at randomization (depende
nt upon study stage)
1.a Criterion met?
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclus
ion N
umber
:2
Criter
ion De
scripti
on:Participants who are wil
ling and able to comply
with all scheduled visits
, vaccination plan, labor
atory tests, lifestyle con
siderations, and other st
udy procedures
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN02A00Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961703
Page 83 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.b Inclusion Number:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participants who are willing and
able to comply with all schedule
d visits, vaccination plan, labora
tory tests, lifestyle consideration
s, and other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:3Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961704
Page 84 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criter
ion De
scripti
on:Healthy participants wh
o are determined by me
dical history, physical e
xamination, and clinical
judgment of the investi
gator to be eligible for i
nclusion in the study
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN03A00
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961705
Page 85 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.c Inclusion Number:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Healthy participants who are det
ermined by medical history, phy
sical examination, and clinical j
udgment of the investigator to b
e eligible for inclusion in the stu
dyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclus
ion Nu
mber:4Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0961706
Page 86 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criter
ion De
scripti
on:Capable of giving perso
nal signed informed co
nsent, which includes c
ompliance with the req
uirements and restrictio
ns listed in the ICD and
in this protocol
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN04A00
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961707
Page 87 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.d Inclusion Number:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Capable of giving personal sign
ed informed consent, which incl
udes compliance with the requir
ements and restrictions listed in
the ICD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:1Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961708
Page 88 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criter
ion D
escrip
tion:Other medical or psychi
atric condition incl. rece
nt (within past year) or
active suicidal ideation/
behavior/lab abnormalit
y that may increase the
risk of study participati
on
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Other medical or psychiatric con
dition incl. recent (within past y
ear) or active suicidal ideation/b
ehavior/lab abnormality that ma
y increase the risk of study parti
cipationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961709
Page 89 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:2
Criterio
n Descr
iption:Known infection with
human immunodeficie
ncy virus (HIV), hepat
itis C virus (HCV), or
hepatitis B virus (HB
V)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX02A00Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961710
Page 90 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.b Exclusion Number:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Known infection with human im
munodeficiency virus (HIV), he
patitis C virus (HCV), or hepatit
is B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961711
Page 91 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criter
ion De
scripti
on:History of severe adver
se reaction associated w
ith a vaccine and/or sev
ere allergic reaction (eg
, anaphylaxis) to any co
mponent of the study in
tervention(s)
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX03A00
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961712
Page 92 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.c Exclusion Number:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
History of severe adverse reactio
n associated with a vaccine and/
or severe allergic reaction (eg, a
naphylaxis) to any component o
f the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion N
umber:4
Criterion D
escription:Receipt of medica
tions intended to
prevent COVID-1
9Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961713
Page 93 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterion m
et?:NO
Criterion I
D: (For Pfiz
er use only)
:EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of medications intended
to prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:8Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961714
Page 94 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Immunocompromised i
ndividuals with known
or suspected immunode
ficiency, as determined
by history and/or labor
atory/physical examina
tion
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX08A00
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961715
Page 95 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.e Exclusion Number:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Immunocompromised individual
s with known or suspected imm
unodeficiency, as determined by
history and/or laboratory/physic
al examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961716
Page 96 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criter
ion De
scripti
on:Bleeding diathesis or c
ondition associated wit
h prolonged bleeding th
at would, in the opinion
of the investigator, cont
raindicate intramuscula
r injection
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX10A00
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961717
Page 97 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.f Exclusion Number:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition
associated with prolonged bleedi
ng that would, in the opinion of
the investigator, contraindicate i
ntramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:11
Criterion Des
cription:Women who are
pregnant or brea
stfeeding
Criterion met
?:NOInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961718
Page 98 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterion ID:
(For Pfizer us
e only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Women who are pregnant or bre
astfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion N
umber:12
Criterion De
scription:Previous vaccinat
ion with any coro
navirus vaccineInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961719
Page 99 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterion m
et?:NO
Criterion ID
: (For Pfizer
use only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Previous vaccination with any c
oronavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:13Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961720
Page 100 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterio
n Descri
ption:Subjects who receive
immunosuppressive t
herapy, such as cytoto
xic agents or systemi
c corticosteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Subjects who receive immunosu
ppressive therapy, such as cytoto
xic agents or systemic corticoste
roidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961721
Page 101 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.j
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:15
Criteri
on Des
criptio
n:Receipt of blood/plasm
a products or immunog
lobulin, from 60 days b
efore study intervention
administration or plann
ed receipt throughout t
he study
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX14A01Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961722
Page 102 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.j Exclusion Number:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma product
s or immunoglobulin, from 60 d
ays before study intervention ad
ministration or planned receipt t
hroughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961723
Page 103 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
2.k
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:16
Criteri
on Des
criptio
n:Participation in other s
tudies involving study
intervention within 28
days prior to study ent
ry and/or during study
participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX15A01Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961724
Page 104 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.k Exclusion Number:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participation in other studies inv
olving study intervention within
28 days prior to study entry and/
or during study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:17
Criterio
n Descri
ption:Previous participatio
n in other studies inv
olving study interven
tion containing lipid
nanoparticlesInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961725
Page 105 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only
):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Previous participation in other s
tudies involving study interventi
on containing lipid nanoparticle
sInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961726
Page 106 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclu
sion
Numb
er:22
Criter
ion D
escrip
tion:Investigator site staff or
Pfizer employees direct
ly involved in the cond
uct of the study, site staf
f otherwise supervised
by the investigator, and
their respective family
members
Criter
ion m
et?:NO
Criter
ion I
D: (F
or Pfi
zer us
e only
):EX21A01Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961727
Page 107 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.m Exclusion Number:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer e
mployees directly involved in th
e conduct of the study, site staff
otherwise supervised by the inv
estigator, and their respective fa
mily membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-28-2020 16:12:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961728
Page 108 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-28-2020 16:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020 16:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020 16:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961729
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***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020 16:13:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:penicillin alle
rgy
Start Date: UNK/UNK/1
995
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020 16:13:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 16:13:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
penicillin allergyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-28-2020 16:13:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-28-2020 16:13:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961730
Page 110 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Aug-28-2020 16:14:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:hernia repair
Start Date: UNK/UNK/199
8
Ongoing: NO
End Date:
UNK/UNK/
1998Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-28-2020 16:14:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 16:14:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hernia repairInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-28-2020 16:14:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-28-2020 16:14:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1998Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961731
Page 111 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.c
Date Location User Value Reason
Sep-21-2020 10:56:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:3
Medical History
Term:inflammation
Start Date: UNK/UNK/19
98
Ongoing: NO
End Date:
UNK/UNK/
1998Transcription Error
Aug-28-2020 16:14:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:inflammed her
nia
Start Date: UNK/UNK/19
98
Ongoing: NO
End Date:
UNK/UNK/
1998Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0961732
Page 112 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.c Line/MH Number:
Date Location User Value Reason
Aug-28-2020 16:14:49
(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-21-2020
12:11:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
2: Clo
sedDiscrepancy has
been closed.
Sep-21-2020
10:56:23
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query
2: Ans
weredTranscription Error
Sep-21-2020
10:56:23
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
inflam
matio
nTranscription Error
Sep-20-2020
03:54:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Saumitra Dubey TMS
QueryQuery
2: Rei
ssued:
Opene
dCoding Query:
Coding cannot
happen with the
existing term.
Kindly update the
term as
INFLAMMATION
and HERNIA in
two separate logs
or keep only
HERNIA here.
Kindly check and
update the data,
else clarify.
Sep-16-2020 ACV0PFEINFP6000 Querycorrect as is; this is
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b)
(6)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0961733
Page 113 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
11:14:48
(UTC-06:00)
Central Time
(US &
Canada)2: Ans
weredwhy the surgery
happened
Sep-16-2020
04:51:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
2: Op
enedMultiple concepts
in the term
INFLAMMED
HERNIA. Split the
term into
INFLAMMATION
and HERNIA and
submit separately.
Thank you.
Sep-16-2020
03:52:06
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
1: Clo
sedDiscrepancy has
been closed.
Sep-09-2020
11:21:36
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredPer INV this is
correct as is;
subject needed
hernia removal due
to "inflamed
hernia"
Sep-09-2020
09:06:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dThank you for
confirming. Please
consider splitting
the term into two
separate entries as
INFLAMMED
HERNIA contains
multiple concepts
and coding of this
term is not
possible as is.
Please reference
section 4.13 in
CRF Completion
Guidelines for
assistance.
Sep-01-2020 ACV0PFEINFP6000 Querycorrect as is,
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961734
Page 114 of 156
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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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
10:58:05
(UTC-06:00)
Central Time
(US &
Canada)1: Ans
weredinflamed hernia is
pertinent diagnosis
for the removal of
the Hernia.
Sep-01-2020
09:28:32
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dCoding cannot
take place with the
term as is. Please
split the term into
INFLAMMATION
and HERNIA and
submit separately.
Aug-31-2020
10:25:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Ans
weredno per subject this
was one condition
Aug-29-2020
11:47:29
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query
1: Op
enedMultiple concepts
in the term
INFLAMMED
HERNIA. Split the
term into
INFLAMMATION
and HERNIA and
submit separately.
Thank you.
Aug-28-2020
16:14:49
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
inflam
med h
erniaInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-28-2020 16:14:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961735
Page 115 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-28-2020 16:14:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1998Initial Entry
1.d
Date Location User Value Reason
Sep-21-2020 10:56:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:hernia
Start Date: UNK/UNK/199
8
Ongoing: NO
End Date:
UNK/UNK/
1998Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0961736
Page 116 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.d Line/MH Number:
Date Location User Value Reason
Sep-21-2020 10:56:44
(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
Sep-21-2020 10:56:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
herniaInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-21-2020 10:56:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-21-2020 10:56:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1998Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0961737
Page 117 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020 16:15:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020 16:15:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
94.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020 16:15:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-28-2020 16:15:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
178.6Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020 16:15:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020 16:15:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29.5Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961738
Page 118 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7.a
Date Location User Value Reason
Aug-28-2020 16:15:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 36.3
Temperature Uni
t:C
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020 16:15:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020 16:15:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.3Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020 16:15:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-28-2020 16:15:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961739
Page 119 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020 16:16:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020 16:16:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
72478Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961740
Page 120 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 19:04:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 19:04:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 19:04:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 19:04:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-28-2020 19:04:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020 19:04:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKMZDGInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961741
Page 121 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 19:04:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BKMZDGInitial Entry
5.b
Date Location User Value Reason
Aug-28-2020 19:04:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKMZDHInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020 19:04:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BKMZDHInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020 19:05:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKMZDJInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-28-2020 19:05:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BKMZDJInitial Entry
5.d
Date Location User Value Reason
Aug-28-2020 19:20:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPFSW6Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961742
Page 122 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.d Sample ID
Date Location User Value Reason
Aug-28-2020 19:20:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPFSW6Initial Entry
5.e
Date Location User Value Reason
Aug-28-2020 19:20:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPFSW7Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-28-2020 19:20:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPFSW7Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961743
Page 123 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 19:55:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 19:55:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 19:56:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 19:55:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-28-2020 19:55:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020 19:56:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY9HSInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961744
Page 124 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 19:56:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPY9HSInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961745
Page 125 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-28-2020 16:16:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020 16:16:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020 16:16:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-28-2020 16:16:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 13:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020 16:16:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-28-2020 16:16:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961746
Page 126 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7. Route:
Date Location User Value Reason
Aug-28-2020 16:16:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-28-2020 16:16:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-28-2020 16:16:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961747
Page 127 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-28-2020 16:17:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961748
Page 128 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-30-2020 07:24:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed As per site
confirmation -
updated PD tracker
Sep-29-2020 16:23:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Subject was
difficult to contact,
took multiple
attempts
Sep-28-2020 04:08:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened PDQ: DOV at this
visit is out of
window (5 day)
from DOV
(28/Aug/2020) at
V1D1VX1L.
Please either
update DOV or
confirm whether
visit is out of
window due to
temporary delay of
vaccination/ else
provide details as
appropriate.
Sep-27-2020 01:42:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-26-2020 12:01:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Sep-26-2020 05:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Please also
complete Nasal
Swab form at this
visit accordingly.
Sep-25-2020 11:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query (autoquery) Query 1: Answered Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961749
Page 129 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-25-2020 11:00:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
Sep-25-2020 03:02:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly
review and
complete ‘Date of
Visit, Nasal Swab,
Vaccination, Vital
Signs' forms at this
visit. Thank you.
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961750
Page 130 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020 11:00:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2.a
Date Location User Value Reason
Sep-25-2020 11:00:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.2
Temperature Unit: C
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-25-2020 11:00:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-25-2020 11:00:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-25-2020 11:00:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961751
Page 131 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Sep-25-2020 11:00:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961752
Page 132 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-26-2020 12:00:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-26-2020 12:00:22
(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-26-2020 12:00:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-26-2020 12:00:22
(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-26-2020 12:00:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-26-2020 12:00:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM5YK0Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961753
Page 133 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.a Sample ID
Date Location User Value Reason
Sep-26-2020 12:00:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM5YK0Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961754
Page 134 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-25-2020 11:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-25-2020 11:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-25-2020 11:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-25-2020 11:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020 09:24Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-25-2020 11:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-25-2020 11:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961755
Page 135 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7. Route:
Date Location User Value Reason
Sep-25-2020 11:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-25-2020 11:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-25-2020 11:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961756
Page 136 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-26-2020 11:37:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/26/2020Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961757
Page 137 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-27-2020 14:03:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020 14:03:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-27-2020 15:35:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-27-2020 14:03:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-27-2020 14:03:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/26/2020Initial Entry
5.a
Date Location User Value Reason
Oct-27-2020 15:35:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNX56KInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961758
Page 138 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.a Sample ID
Date Location User Value Reason
Oct-27-2020 15:35:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNX56KInitial Entry
5.b
Date Location User Value Reason
Oct-27-2020 15:35:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNX56LInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-27-2020 15:35:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNX56LInitial Entry
5.c
Date Location User Value Reason
Oct-27-2020 15:35:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR031MInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-27-2020 15:35:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR031MInitial Entry
5.d
Date Location User Value Reason
Oct-27-2020 15:35:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR031NInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961759
Page 139 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.d Sample ID
Date Location User Value Reason
Oct-27-2020 15:35:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR031NInitial Entry
5.e
Date Location User Value Reason
Oct-27-2020 15:35:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR031PInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-27-2020 15:35:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR031PInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961760
Page 140 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/12/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-13-2020 10:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961761
Page 141 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/12/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Assessments
Date Location User Value Reason
Oct-13-2020 10:54:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 10:54:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form is
not entered. Please
review and update as
appropriate.
Oct-13-2020 10:54:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961762
Page 142 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/12/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Contact Type:
Date Location User Value Reason
Oct-13-2020 10:54:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Oct-13-2020 10:54:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Oct/12/2020
Contact Outcome:
VISIT NOT REQUIRED, INV
ESTIGATOR DECISIONInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961763
Page 143 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-26-2020 11:37:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-26-2020 11:37:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-26-2020 11:37:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961764
Page 144 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Sep-28-2020 11:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961765
Page 145 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Sep-28-2020 11:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-28-2020 11:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-28-2020 11:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cellulitis in Left legInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-28-2020 11:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/8/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-28-2020 11:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/16/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0961766
Page 146 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-28-2020 11:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-10-2020 21:12:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Nov-10-2020 11:08:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Covid test was
performed on
14Sep2020, SAE
FUP will be sent
Nov-04-2020 02:30:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical - SAE
update just
submitted included
COVID test
performed on
04Sep2020;
however, the SAE
began on 08Sep and
hospitalization
began 14Sep. Was
this test performed
on hospital
admission ie 9/14
rather than 9/4; if so,
please send SAE
update
Nov-04-2020 02:28:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Candidate Clinical - SAE
update just
submitted included
COVID test
performed on
04Sep2020;
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0961767
Page 147 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
however, the SAE
began on 08Sep and
hospitalization
began 14Sep. Was
this test performed
on hospital
admission ie 9/14
rather than 9/4; if so,
please send SAE
update
Oct-29-2020 12:37:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Oct-29-2020 08:44:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered this has been sent to
monitor and and
added to followup
Oct-28-2020 00:02:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened Clinical - Thank
you; please include
the COVID test
DATE with the test
result in the safety
followup
Oct-27-2020 17:05:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered SAE follow up form
submitted, patient
did receive COVID
test and tested
negative.
Oct-23-2020 19:46:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE form
[#2020371862] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the
results.
Sep-29-2020 05:30:18
(UTC-06:00) CentralACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961768
Page 148 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Time (US & Canada)
Sep-28-2020 11:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Cellulitis in
Left leg: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Sep-28-2020 11:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important ser
ious 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
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961769
Page 149 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-28-2020 11:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-08-2020 10:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Patricia
BancheroQuery 1: Closed Response satisfies
query
Oct-08-2020 09:18:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-08-2020 09:18:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
BACTERIAL INFECTIO
NNew Information
Sep-30-2020 20:59:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Patricia
BancheroQuery 1: Opened GPDCLIN: Per
CRF completion
requirements
(8.47.8), if Other,
please indicate what
the event cellulitis
is due to. Thank
you
Sep-28-2020 11:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
CellulitisInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961770
Page 150 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-28-2020 11:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-28-2020 11:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-28-2020 11:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-28-2020 11:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-28-2020 11:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-29-2020 05:30:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020371862Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0961771
Page 151 of 156
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-03-2021 10:23:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/19/2021Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0961772
Page 152 of 156
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-24-2021 16:02:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2updated
Jan-21-2021 12:07:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT willing to ret
urn for Vaccination 3 OR otherw
ise not eligibleInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0961773
Page 153 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-21-2021 12:07:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Feb-24-2021
23:06:37
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_35
Feb-24-2021
16:04:50
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dupdated
Feb-22-2021
11:28:52
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7349945;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Jan-21-2021
12:07:35
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000 Data
Entry
:
ASSE
SS ELInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0961774
Page 154 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Canada) IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ON
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961775
Page 155 of 156
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-26-2020 11:37:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-28-2020 16:16:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-28-2020 16:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-26-2020 11:37:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/26/2020Initial Entry
Aug-28-2020 16:16:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
Aug-28-2020 16:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961776
Page 156 of 156
***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, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841317 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-11-2020 11:06:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3f86\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961777