Document text
Page 1 of 247
***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: 10841266 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
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961375
Page 2 of 247
***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: 10841266 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/22/2020
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961376
Page 3 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10841266]
2.Birth Date: /1943
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961377
Page 4 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/22/2020
2.Erroneous Visit
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961378
Page 5 of 247
***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: 10841266 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
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
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961379
Page 6 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
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
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961380
Page 7 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
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
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961381
Page 8 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/22/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961382
Page 9 of 247
***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: 10841266 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:[Levaquin allergy]
Start Date: UNK/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[environmental allergies]
Start Date: UNK/UNK/1975
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[amputation of 5 toes on right foot]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Amputation of left big toe]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Amputation of toe on left foot]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961383
Page 10 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[CORONARY ARTERIAL BYPASS GRAFTS]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Cataract Removal]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Bilateral Cataracts]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Ocular hypertension]
Start Date: Jun/UNK/2020
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Congestive Heart failure]
Start Date: UNK/UNK/2005
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertension]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961384
Page 11 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/2012
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Type 2 Diabetes]
Start Date: UNK/UNK/1980
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[atrophy to left hand]
Start Date: Aug/22/2020
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[gangrene on all toes on right foot]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[gangrene on left big toe]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2020
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[gangrene on toe left foot]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961385
Page 12 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[erectile dysfunction]
Start Date: UNK/UNK/1985
Ongoing: YES
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961386
Page 13 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Aug/22/2020
2.Weight: [79.0]
3.Unit: kg
4.Height: [166.4]
5.Unit: cm
6.Body Mass Index: [28.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961387
Page 14 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/22/2020
2.Randomization Number: [237238]
3.Randomization Group: [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961388
Page 15 of 247
***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: 10841266 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/22/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY97P]
5.bSample ID [BPY97R]
5.cSample ID [BPY97S]
5.dSample ID [BPFSZH]
5.eSample ID [BPFSZJ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961389
Page 16 of 247
***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: 10841266 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/22/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY96M]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961390
Page 17 of 247
***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: 10841266 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/22/2020 13:51
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
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961391
Page 18 of 247
***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: 10841266 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
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961392
Page 19 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961393
Page 20 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961394
Page 21 of 247
***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: 10841266 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/14/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPC0H5]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961395
Page 22 of 247
***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: 10841266 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/14/2020 11:26
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
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961396
Page 23 of 247
***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: 10841266 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
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961397
Page 24 of 247
***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: 10841266 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/12/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNX5G9]
5.bSample ID [BNX5GB]
5.cSample ID [BKSCMK]
5.dSample ID [BKSCML]
5.eSample ID [BKSCMM]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961398
Page 25 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961399
Page 26 of 247
***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: 10841266 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 [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961400
Page 27 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961401
Page 28 of 247
***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: 10841266 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 [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961402
Page 29 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961403
Page 30 of 247
***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: 10841266 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 [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961404
Page 31 of 247
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 10841266 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:
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961405
Page 32 of 247
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 10841266 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: [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961406
Page 33 of 247
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 10841266 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 [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961407
Page 34 of 247
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 10841266 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 [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961408
Page 35 of 247
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 10841266 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?
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961409
Page 36 of 247
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 10841266 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:
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961410
Page 37 of 247
***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: 10841266 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:
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961411
Page 38 of 247
***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: 10841266 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 [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961412
Page 39 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/15/2020Form: 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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961413
Page 40 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/15/2020Form: 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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961414
Page 41 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/15/2020Form: 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: 10841266 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:
Sep/15/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961415
Page 42 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Oct/13/2020Form: 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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961416
Page 43 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Oct/13/2020Form: 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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961417
Page 44 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Oct/13/2020Form: 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: 10841266 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/13/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961418
Page 45 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 3 - Unscheduled Visit on
Nov/04/2020Form: 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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/4/2020
2.Erroneous Visit
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961419
Page 46 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 3 - Unscheduled Visit on
Nov/04/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961420
Page 47 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 3 - Unscheduled Visit on
Nov/04/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 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? NO
If No, why?
[Answering machine full, subject did not answer 2 calls]
3.Comments: [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961421
Page 48 of 247
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 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/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961422
Page 49 of 247
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Jan/12/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961423
Page 50 of 247
***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: 10841266 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:
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961424
Page 51 of 247
***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: 10841266 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 [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961425
Page 52 of 247
***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: 10841266 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 Acute Emphysematous Chole
cystitis Nov/3/2020 UNK:U
NK NO
End Date Time:
Jan/12/2021 UNK:UNK
Repeating
Pages
2.ADVERSE EVE
NT 2 Rhabdomolysis Nov/2/2020 UNK:U
NK NO
End Date Time:
Nov/13/2020 UNK:UNK
Repeating
Pages
3.ADVERSE EVE
NT 3 Atrial Fibrillation with RVR Nov/3/2020 UNK:U
NK YES Repeating
Pages
4.ADVERSE EVE
NT 4 Acute Kidney Injury Nov/3/2020 UNK:U
NK YES Repeating
Pages
5.ADVERSE EVE
NT 5 Sepsis Nov/3/2020 UNK:U
NK NO
End Date Time:
Jan/12/2021 UNK:UNK
Repeating
Pages
6.ADVERSE EVE
NT 6 Left lower extremity weaknes
s Oct/28/2020 UNK:
UNK YES Repeating
Pages
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961426
Page 53 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 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)[Acute Emphysematous Cholecystitis]
4.Start Date Time: Nov/3/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/12/2021 UNK:UNK
6.Toxicity Grade: 4
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?
YES
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?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[bacteria]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961427
Page 54 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:FATAL
14.Did the adverse event cause the subject
to be discontinued from the study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2020459195]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961428
Page 55 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Rhabdomolysis]
4.Start Date Time: Nov/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/13/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[dehydration]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961429
Page 56 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961430
Page 57 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Atrial Fibrillation with RVR]
4.Start Date Time: Nov/3/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[CAD]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961431
Page 58 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961432
Page 59 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 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: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Acute Kidney Injury]
4.Start Date Time: Nov/3/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Dehydration]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961433
Page 60 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961434
Page 61 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 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: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Sepsis]
4.Start Date Time: Nov/3/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/12/2021 UNK:UNK
6.Toxicity Grade: 4
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?
YES
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Klebsiella Oxytoca, Escherichia coli, Klebsiella pneumonia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961435
Page 62 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:FATAL
14.Did the adverse event cause the subject
to be discontinued from the study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2020459195]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961436
Page 63 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 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: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Left lower extremity weakness]
4.Start Date Time: Oct/28/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a study
Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[sepsis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
14.Did the adverse event cause the subject
to be discontinued from the study?NO
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961437
Page 64 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961438
Page 65 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Actio
nForm Instance
1. Repeating Pages
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961439
Page 66 of 247
***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: 10841266 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[ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961440
Page 67 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medicatio
ns Pre-specifiedName of MedicationStart D
ateForm Instan
ce
1.1 VACCINATION
S NO INFLUENZA VIRUS VACCINE QUAD
RIVALENT 240 MCG IM Nov/8/2
020 Repeating
Pages
2.2 VACCINATION
S NO Pneumococcal Polysaccharide Vaccine 0.
5mL IM Nov/8/2
020 Repeating
Pages
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961441
Page 68 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications Pre-specified: NO
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).[INFLUENZA VIRUS VACCINE QUADRIVALENT 240 MCG IM]
5.Date: Nov/8/2020
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961442
Page 69 of 247
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: VACCINATIONS
3.Concomitant Medications Pre-specified: NO
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).[Pneumococcal Polysaccharide Vaccine 0.5mL IM]
5.Date: Nov/8/2020
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961443
Page 70 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionDose Descrip
tionForm Instance
1. Repeating
Pages
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961444
Page 71 of 247
***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: 10841266 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?
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961445
Page 72 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961446
Page 73 of 247
***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: 10841266 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?
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961447
Page 74 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961448
Page 75 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961449
Page 76 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961450
Page 77 of 247
***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: 10841266 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:
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961451
Page 78 of 247
***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: 10841266 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?
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961452
Page 79 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961453
Page 80 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961454
Page 81 of 247
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961455
Page 82 of 247
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961456
Page 83 of 247
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 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 [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961457
Page 84 of 247
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 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 [ ]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961458
Page 85 of 247
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961459
Page 86 of 247
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Not Applicable Comments
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961460
Page 87 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Not Applicable
//Comments
2.Primary Reason for Unblinding: Not Applicable Comments
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961461
Page 88 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961462
Page 89 of 247
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Jan/15/2021
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Sepsis]
2.bCause of Death Status: SECONDARY CAUSE OF DEATH
Cause of Death: [Acute emphysematous cholecystitis]
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961463
Page 90 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Jan/12/2021
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961464
Page 91 of 247
***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: 10841266 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
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961465
Page 92 of 247
***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: 10841266 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
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961466
Page 93 of 247
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - Comments
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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-02-2021 12:04:23 (UTC-06:00) Central Time
(US & Canada)Not applicable
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961467
Page 94 of 247
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-05-2021 08:58:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormMar-02-2021 12:04:58 (UTC-06:00) Central Time
(US & Canada)Not applicable
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961468
Page 95 of 247
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-05-2021 08:58:27 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961469
Page 96 of 247
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-02-2021 17:18:37 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormMar-02-2021 12:01:40 (UTC-06:00) Central Time
(US & Canada)Not applicable
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961470
Page 97 of 247
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-02-2021 17:18:37 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961471
Page 98 of 247
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Mar-02-2021 17:18:37 (UTC-06:00) Central Time (US
& Canada)Not Applicable
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961472
Page 99 of 247
***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: 10841266 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 Jan-26-2021 15:00:09 (UTC-06:00) Central Time (US
& Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-22-2021 18:41:50 (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-22-2021 15:18:30 (UTC-06:00) Central Time (US
& Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 16:15:28 (UTC-06:00) Central Time (US
& Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-20-2020 16:57:28 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961473
Page 100 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Approved Nov-06-2020 12:08:44 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-05-2020 10:24:59 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-20-2020 15:31:48 (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.
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961474
Page 101 of 247
***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: 10841266 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-22-2020 14:46:25
(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-22-2020 14:46:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961475
Page 102 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-22-2020 14:46:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/22/2020Initial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961476
Page 103 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-22-2020 14:46:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10841266Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-22-2020 14:46:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1943Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-22-2020 14:47:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-22-2020 14:47:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR OF SP
ANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-22-2020 14:47:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961477
Page 104 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-22-2020 14:47:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/22/2020Initial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961478
Page 105 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Male or female participants be
tween the ages of 18 and 55 ye
ars, inclusive, 65 and 85 years,
inclusive, or 18 and 85 years, i
nclusive, at randomization (de
pendent upon study stage)
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Male or female participants between the
ages of 18 and 55 years, inclusive, 65 an
d 85 years, inclusive, or 18 and 85 years
, inclusive, at randomization (dependent
upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f84\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-2021-5683-0961479
Page 106 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusio
n Num
ber:2
Criteri
on Desc
ription:Participants who are willing a
nd able to comply with all sch
eduled visits, vaccination plan
, laboratory tests, lifestyle con
siderations, and other study pr
ocedures
Criteri
on met
?:YES
Criteri
on ID: (
For Pfi
zer use
only):IN02A00Initial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961480
Page 107 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.b Inclusion Number:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participants who are willing and able to
comply with all scheduled visits, vaccin
ation plan, laboratory tests, lifestyle con
siderations, and other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-22-2020 14:47:26
(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-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Desc
ription:Healthy participants who are
determined by medical history
, physical examination, and cli
nical judgment of the investig
ator to be eligible for inclusio
n in the study
Criteri
on met
?:YESInitial Entry
090177e196ae3f84\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-2021-5683-0961481
Page 108 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on ID: (
For Pfi
zer use
only):IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Healthy participants who are determine
d by medical history, physical examinati
on, and clinical judgment of the investig
ator to be eligible for inclusion in the st
udyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-22-2020 14:47:26
(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-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusio
n Num
ber:4Initial Entry
090177e196ae3f84\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-2021-5683-0961482
Page 109 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterio
n Descr
iption:Capable of giving personal si
gned informed consent, which
includes compliance with the
requirements and restrictions l
isted in the ICD and in this pr
otocol
Criterio
n met?:YES
Criterio
n ID: (F
or Pfize
r use on
ly):IN04A00
1.d Inclusion Number:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Capable of giving personal signed infor
med consent, which includes complianc
e with the requirements and restrictions
listed in the ICD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-22-2020 14:47:26
(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-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi1Initial Entry
090177e196ae3f84\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-2021-5683-0961483
Page 110 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
on Nu
mber:
Criteri
on Des
criptio
n:Other medical or psychiatric c
ondition incl. recent (within p
ast year) or active suicidal ide
ation/behavior/lab abnormalit
y that may increase the risk of
study participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Other medical or psychiatric condition i
ncl. recent (within past year) or active s
uicidal ideation/behavior/lab abnormalit
y that may increase the risk of study par
ticipationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
090177e196ae3f84\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-2021-5683-0961484
Page 111 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion
Number:2
Criterion
Descripti
on:Known infection with huma
n immunodeficiency virus (
HIV), hepatitis C virus (HC
V), or hepatitis B virus (HB
V)
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX02A00Initial Entry
2.b Exclusion Number:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Known infection with human immunod
eficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-22-2020 14:47:26
(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-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
090177e196ae3f84\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-2021-5683-0961485
Page 112 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:3
Criterio
n Descr
iption:History of severe adverse reac
tion associated with a vaccine
and/or severe allergic reaction
(eg, anaphylaxis) to any comp
onent of the study interventio
n(s)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX03A00Initial Entry
2.c Exclusion Number:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
History of severe adverse reaction assoc
iated with a vaccine and/or severe allerg
ic reaction (eg, anaphylaxis) to any com
ponent of the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-22-2020 14:47:26
(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-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
090177e196ae3f84\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-2021-5683-0961486
Page 113 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:4
Criterion Desc
ription:Receipt of medication
s intended to prevent
COVID-19
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX04A00Initial Entry
2.d Exclusion Number:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of medications intended to prev
ent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-22-2020 14:47:26
(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-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:8Initial Entry
090177e196ae3f84\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-2021-5683-0961487
Page 114 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterio
n Descri
ption:Immunocompromised individ
uals with known or suspected
immunodeficiency, as determ
ined by history and/or laborat
ory/physical examination
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Immunocompromised individuals with
known or suspected immunodeficiency,
as determined by history and/or laborato
ry/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-22-2020 14:47:26
(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-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Num10Initial Entry
090177e196ae3f84\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-2021-5683-0961488
Page 115 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
ber:
Criterio
n Descr
iption:Bleeding diathesis or conditio
n associated with prolonged b
leeding that would, in the opi
nion of the investigator, contr
aindicate intramuscular inject
ion
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition associat
ed with prolonged bleeding that would,
in the opinion of the investigator, contra
indicate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-22-2020 14:47:26
(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-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-22-2020 14:47:26 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f84\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-2021-5683-0961489
Page 116 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-06:00) Central Time
(US & Canada)Exclusion Numb
er:11
Criterion Descri
ption:Women who are pre
gnant or breastfeedi
ng
Criterion met?: NO
Criterion ID: (F
or Pfizer use onl
y):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Women who are pregnant or breastfeedi
ngInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-22-2020 14:47:26
(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-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Num
ber:12
Criterion Descr
iption:Previous vaccination
with any coronavirus
vaccine
Criterion met?: NOInitial Entry
090177e196ae3f84\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-2021-5683-0961490
Page 117 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterion ID: (
For Pfizer use
only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Previous vaccination with any coronavir
us vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-22-2020 14:47:26
(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-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion
Number:13
Criterion
Descriptio
n:Subjects who receive immu
nosuppressive therapy, suc
h as cytotoxic agents or sys
temic corticosteroids
Criterion
met?:NO
Criterion
ID: (For P
fizer use o
nly):EX13A01Initial Entry
090177e196ae3f84\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-2021-5683-0961491
Page 118 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.i Exclusion Number:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Subjects who receive immunosuppressi
ve therapy, such as cytotoxic agents or s
ystemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-22-2020 14:47:26
(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-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:15
Criterio
n Descri
ption:Receipt of blood/plasma prod
ucts or immunoglobulin, fro
m 60 days before study interv
ention administration or plan
ned receipt throughout the stu
dy
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX14A01Initial Entry
090177e196ae3f84\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-2021-5683-0961492
Page 119 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.j Exclusion Number:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma products or im
munoglobulin, from 60 days before stud
y intervention administration or planned
receipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-22-2020 14:47:26
(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-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae3f84\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-2021-5683-0961493
Page 120 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
2.k
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:16
Criterio
n Descri
ption:Participation in other studies
involving study intervention
within 28 days prior to study
entry and/or during study pa
rticipation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX15A01Initial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961494
Page 121 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.k Exclusion Number:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participation in other studies involving
study intervention within 28 days prior
to study entry and/or during study parti
cipationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-22-2020 14:47:26
(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-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion
Number:17
Criterion
Descriptio
n:Previous participation in o
ther studies involving stud
y intervention containing l
ipid nanoparticles
Criterion
met?:NO
Criterion
ID: (For P
fizer use o
nly):EX16A01Initial Entry
090177e196ae3f84\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-2021-5683-0961495
Page 122 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.l Exclusion Number:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Previous participation in other studies i
nvolving study intervention containing l
ipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-22-2020 14:47:26
(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-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:22
Criteri
on Des
criptio
n:Investigator site staff or Pfizer
employees directly involved i
n the conduct of the study, site
staff otherwise supervised by t
he investigator, and their resp
ective family members
Criteri
on met
?:NOInitial Entry
090177e196ae3f84\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-2021-5683-0961496
Page 123 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on ID:
(For Pf
izer us
e only)
:EX21A01
2.m Exclusion Number:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer employe
es directly involved in the conduct of th
e study, site staff otherwise supervised
by the investigator, and their respective
family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-22-2020 14:47:26
(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-22-2020 14:47:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae3f84\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-2021-5683-0961497
Page 124 of 247
***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: 10841266 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-22-2020 14:48:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-22-2020 14:48:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-22-2020 14:48:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961498
Page 125 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Aug-22-2020 14:52:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Term
:Levaquin allerg
y
Start Date: UNK/UNK/200
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-22-2020 14:52:15
(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-22-2020 14:52:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Levaquin allergyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-22-2020 14:52:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-22-2020 14:52:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-22-2020 14:52:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:environmental aller
giesInitial Entry
090177e196ae3f84\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-2021-5683-0961499
Page 126 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Start Date: UNK/UNK/1975
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Aug-22-2020 14:52:59
(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-22-2020 14:52:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
environmental allergiesInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-22-2020 14:52:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1975Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-22-2020 14:52:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-22-2020 15:15:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:amputation of 5 toes o
n right foot
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011Transcription Error
Aug-22-2020 15:05:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3Initial Entry
090177e196ae3f84\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-2021-5683-0961500
Page 127 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Medical Histo
ry Term:amputation of 5 toes o
n right foor
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.c Line/MH Number:
Date Location User Value Reason
Aug-22-2020 15:05:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 15:15:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
amputation of 5 toes on right footTranscription Error
Aug-22-2020 15:05:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
amputation of 5 toes on right foorInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-22-2020 15:05:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-22-2020 15:05:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
1.d
Date Location User Value Reason
Aug-22-2020 15:06:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:4Initial Entry
090177e196ae3f84\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-2021-5683-0961501
Page 128 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Medical History T
erm:Amputation of left bi
g toe
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
1.d Line/MH Number:
Date Location User Value Reason
Aug-22-2020 15:06:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 15:06:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Amputation of left big toeInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-22-2020 15:06:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-22-2020 15:06:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
1.e
Date Location User Value Reason
Aug-22-2020 15:08:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:Amputation of toe on l
eft foot
Start Date: UNK/UNK/2017Initial Entry
090177e196ae3f84\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-2021-5683-0961502
Page 129 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Ongoing: NO
End Date:
UNK/UNK/2017
1.e Line/MH Number:
Date Location User Value Reason
Aug-22-2020 15:08:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 15:08:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Amputation of toe on left footInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-22-2020 15:08:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-22-2020 15:08:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.f
Date Location User Value Reason
Aug-24-2020 11:00:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:6
Medical His
tory Term:CORONARY ARTERIA
L BYPASS GRAFTS
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005Transcription Error
090177e196ae3f84\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-2021-5683-0961503
Page 130 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-22-2020 15:09:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:Bypass Graft
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/20
05Initial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961504
Page 131 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.f Line/MH Number:
Date Location User Value Reason
Aug-22-2020 15:09:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
12:02:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Aug-24-2020
11:00:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription
Error
Aug-24-2020
11:00:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CORONARY ARTERI
AL BYPASS GRAFTSTranscription
Error
Aug-23-2020
11:33:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Opened Clarify BYPASS
GRAFT as
follows...Are you
reporting
CORONARY
ARTERIAL
BYPASS
GRAFTS or the
term POPLITEAL
ARTERY
BYPASS
GRAFT?Or
others? If so,
please edit to such.
Otherwise, please
edit to spell out
the term. Thank
you.
Aug-22-2020
15:09:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Bypass GraftInitial Entry
1.f Start Date:
Date Location User Value Reason
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0961505
Page 132 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-22-2020 15:09:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-22-2020 15:09:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.g
Date Location User Value Reason
Aug-22-2020 15:10:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Ter
m:Cataract Removal
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/20
15Initial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0961506
Page 133 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.g Line/MH Number:
Date Location User Value Reason
Aug-22-2020 15:10:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 15:10:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Cataract RemovalInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-22-2020 15:10:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-22-2020 15:10:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.h
Date Location User Value Reason
Aug-22-2020 15:11:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Ter
m:Bilateral Cataracts
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/20
15Initial Entry
090177e196ae3f84\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-2021-5683-0961507
Page 134 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.h Line/MH Number:
Date Location User Value Reason
Aug-22-2020 15:11:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 15:11:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Bilateral CataractsInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-22-2020 15:11:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-22-2020 15:11:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.i
Date Location User Value Reason
Aug-22-2020 15:13:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Number: 9
Medical History Te
rm:Ocular hypertens
ion
Start Date: Jun/UNK/2020
Ongoing: YESTranscription Error
Aug-22-2020 15:12:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Te
rm:Ocular hypertens
ion
Start Date: UNK/UNK/2020
Ongoing: YESInitial Entry
090177e196ae3f84\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-2021-5683-0961508
Page 135 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.i Line/MH Number:
Date Location User Value Reason
Aug-22-2020 15:12:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 15:12:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Ocular hypertensionInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-22-2020 15:13:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-22-2020 15:13:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/2020Transcription Error
Aug-22-2020 15:12:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
22/Aug/2020. Please
review and update as
appropriate.
Aug-22-2020 15:12:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2020Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-22-2020 15:12:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Aug-22-2020 15:13:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 10Initial Entry
090177e196ae3f84\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-2021-5683-0961509
Page 136 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Medical History T
erm:Congestive Heart fa
ilure
Start Date: UNK/UNK/2005
Ongoing: YES
1.j Line/MH Number:
Date Location User Value Reason
Aug-22-2020 15:13:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 15:13:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Congestive Heart failureInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-22-2020 15:13:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-22-2020 15:13:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Aug-22-2020 15:14:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 11
Medical History Term
:Hypertension
Start Date: UNK/UNK/201
8
Ongoing: YESInitial Entry
090177e196ae3f84\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-2021-5683-0961510
Page 137 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.k Line/MH Number:
Date Location User Value Reason
Aug-22-2020 15:14:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 15:14:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-22-2020 15:14:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-22-2020 15:14:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Aug-22-2020 15:14:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 12
Medical History Te
rm:Hypercholesterole
mia
Start Date: UNK/UNK/2012
Ongoing: YESInitial Entry
090177e196ae3f84\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-2021-5683-0961511
Page 138 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.l Line/MH Number:
Date Location User Value Reason
Aug-22-2020 15:14:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 15:14:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HypercholesterolemiaInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-22-2020 15:14:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-22-2020 15:14:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Aug-22-2020 15:14:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 13
Medical History Term
:Type 2 Diabetes
Start Date: UNK/UNK/198
0
Ongoing: YESInitial Entry
090177e196ae3f84\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-2021-5683-0961512
Page 139 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.m Line/MH Number:
Date Location User Value Reason
Aug-22-2020 15:14:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 15:14:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Type 2 DiabetesInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-22-2020 15:14:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-22-2020 15:14:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Aug-22-2020 15:15:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 14
Medical History Ter
m:atrophy to left ha
nd
Start Date: Aug/22/2020
Ongoing: YESInitial Entry
090177e196ae3f84\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-2021-5683-0961513
Page 140 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.n Line/MH Number:
Date Location User Value Reason
Aug-22-2020 15:15:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 15:15:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
atrophy to left handInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-24-2020 06:01:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed As per site
confirmation
Aug-22-2020 15:19:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered finding was noted
during the physical
exam that occurred
before the dose.
Aug-22-2020 15:15:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
22/Aug/2020. Please
review and update as
appropriate.
Aug-22-2020 15:15:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/22/2020Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-22-2020 15:15:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Aug-22-2020 15:16:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:15Initial Entry
090177e196ae3f84\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-2021-5683-0961514
Page 141 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Medical Histor
y Term:gangrene on all toes on
right foot
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.o Line/MH Number:
Date Location User Value Reason
Aug-22-2020 15:16:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 15:16:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
gangrene on all toes on right footInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-22-2020 15:16:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-22-2020 15:16:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
1.p
Date Location User Value Reason
Aug-22-2020 15:18:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numbe
r:16
Medical History
Term:gangrene on left bi
g toe
Start Date: UNK/UNK/2012Transcription Error
090177e196ae3f84\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-2021-5683-0961515
Page 142 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Ongoing: NO
End Date:
UNK/UNK/202
0
Aug-22-2020 15:16:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:16
Medical History
Term:gangrene on left bi
g toe
Start Date: UNK/UNK/2020
Ongoing: NO
End Date:
UNK/UNK/202
0Initial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961516
Page 143 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.p Line/MH Number:
Date Location User Value Reason
Aug-22-2020 15:16:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 15:16:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
gangrene on left big toeInitial Entry
1.p Start Date:
Date Location User Value Reason
Aug-22-2020 15:18:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-22-2020 15:18:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Transcription Error
Aug-22-2020 15:16:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
22/Aug/2020. Please
review and update as
appropriate.
Aug-22-2020 15:16:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2020Initial Entry
1.p Ongoing:
Date Location User Value Reason
Aug-22-2020 15:16:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2020Initial Entry
1.q
Date Location User Value Reason
Aug-22-2020 15:17:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 17Initial Entry
090177e196ae3f84\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-2021-5683-0961517
Page 144 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Medical History T
erm:gangrene on toe left
foot
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961518
Page 145 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.q Line/MH Number:
Date Location User Value Reason
Aug-22-2020 15:17:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 15:17:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
gangrene on toe left footInitial Entry
1.q Start Date:
Date Location User Value Reason
Aug-22-2020 15:17:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.q Ongoing:
Date Location User Value Reason
Aug-22-2020 15:17:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.r
Date Location User Value Reason
Aug-22-2020 15:17:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 18
Medical History Ter
m:erectile dysfuncti
on
Start Date: UNK/UNK/1985
Ongoing: YESInitial Entry
090177e196ae3f84\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-2021-5683-0961519
Page 146 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.r Line/MH Number:
Date Location User Value Reason
Aug-22-2020 15:17:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-22-2020 15:17:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
erectile dysfunctionInitial Entry
1.r Start Date:
Date Location User Value Reason
Aug-22-2020 15:17:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.r Ongoing:
Date Location User Value Reason
Aug-22-2020 15:17:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f84\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-2021-5683-0961520
Page 147 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Aug-22-2020 14:50:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/22/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-22-2020 14:50:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
79.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-22-2020 14:50:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-22-2020 14:50:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
166.4Initial Entry
5. Unit:
Date Location User Value Reason
Aug-22-2020 14:50:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-22-2020 14:50:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28.5Initial Entry
7.a
Date Location User Value Reason
Aug-22-2020 14:50:49 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3f84\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-2021-5683-0961521
Page 148 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-06:00) Central Time
(US & Canada)Record Identifier:: 1
Temperature: 36.2
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-22-2020 14:50:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-22-2020 14:50:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
36.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-22-2020 14:50:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-22-2020 14:50:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f84\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-2021-5683-0961522
Page 149 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-22-2020 14:51:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/22/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-22-2020 14:51:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
237238Initial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961523
Page 150 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-22-2020 15:09:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-22-2020 15:09:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-22-2020 15:09:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-22-2020 15:09:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-22-2020 15:09:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/22/2020Initial Entry
5.a
Date Location User Value Reason
Aug-22-2020 15:09:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY97PInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-22-2020 15:09:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPY97PInitial Entry
090177e196ae3f84\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-2021-5683-0961524
Page 151 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.b
Date Location User Value Reason
Aug-22-2020 15:10:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY97RInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-22-2020 15:10:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPY97RInitial Entry
5.c
Date Location User Value Reason
Aug-22-2020 15:10:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY97SInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-22-2020 15:10:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPY97SInitial Entry
5.d
Date Location User Value Reason
Aug-22-2020 15:10:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPFSZHInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-22-2020 15:10:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPFSZHInitial Entry
5.e
Date Location User Value Reason
Aug-22-2020 15:11:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPFSZJInitial Entry
090177e196ae3f84\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961525
Page 152 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.e Sample ID
Date Location User Value Reason
Aug-22-2020 15:11:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPFSZJInitial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961526
Page 153 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-22-2020 15:11:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-22-2020 15:11:14
(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-22-2020 15:11:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-22-2020 15:11:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-22-2020 15:11:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/22/2020Initial Entry
5.a
Date Location User Value Reason
Aug-22-2020 15:11:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY96MInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-22-2020 15:11:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPY96MInitial Entry
090177e196ae3f84\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-2021-5683-0961527
Page 154 of 247
***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: 10841266 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-22-2020 14:51:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-22-2020 14:51:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-22-2020 14:51:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-22-2020 14:51:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/22/2020 13:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-22-2020 14:51:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-22-2020 14:51:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-22-2020 14:51:36 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3f84\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-2021-5683-0961528
Page 155 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-06:00) Central Time
(US & Canada)(autocalc) INTRAMUSCULAR
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-22-2020 14:51:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION 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-22-2020 14:51:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961529
Page 156 of 247
***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: 10841266 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-22-2020 14:51:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJE
CTInitial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961530
Page 157 of 247
***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: 10841266 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 14:48:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered no COVID illness visit
per PI
Oct-03-2020 02:41:57
(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
12SEP2020. But there
is no COVID Illness
visit reported in the
database. Please clarify.
Sep-14-2020 12:13:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
090177e196ae3f84\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-2021-5683-0961531
Page 158 of 247
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Sep-14-2020 12:13:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020Initial Entry
2.a
Date Location User Value Reason
Sep-14-2020 12:13:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.9
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-14-2020 12:13:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-14-2020 12:13:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-14-2020 12:13:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-14-2020 12:13:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f84\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-2021-5683-0961532
Page 159 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-14-2020 14:12:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-14-2020 14:12:29
(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-14-2020 14:12:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-14-2020 14:12:29
(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-14-2020 14:12:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
Sep-14-2020 14:12:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPC0H5Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-14-2020 14:12:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BPC0H5Initial Entry
090177e196ae3f84\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-2021-5683-0961533
Page 160 of 247
***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: 10841266 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-14-2020 12:14:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-14-2020 12:14:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-14-2020 12:14:05
(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-14-2020 12:14:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020 11:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-14-2020 12:14:05
(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-14-2020 12:14:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-14-2020 12:14:05 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae3f84\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-2021-5683-0961534
Page 161 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(UTC-06:00) Central Time
(US & Canada)(autocalc) INTRAMUSCULAR
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-14-2020 12:14:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION 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-14-2020 12:14:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961535
Page 162 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-17-2020 12:22:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Query will be moved to
the SUBJECT STATUS
page.
Nov-13-2020 23:08:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened RQ1: Thank you for
the response. Please
consider to follow-up
and confirm for
reported Illness eDiary
response on 10 &
31OCT2020. Please
update or clarify.
Nov-13-2020 17:41:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered unable to complete
visit, subject has not
answered calls nor
called us back, we will
continue trying
Nov-10-2020 08:55:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Illness eDiary: 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 10 &
31OCT2020. But there
is no COVID Illness
visit reported in the
database.
Oct-12-2020 14:37:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
090177e196ae3f84\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-2021-5683-0961536
Page 163 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 16:49:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 16:49:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020 16:49:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-12-2020 16:49:40
(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-12-2020 16:49:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/12/2020Initial Entry
5.a
Date Location User Value Reason
Oct-12-2020 16:49:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNX5G9Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-12-2020 16:49:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BNX5G9Initial Entry
090177e196ae3f84\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-2021-5683-0961537
Page 164 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.b
Date Location User Value Reason
Oct-12-2020 16:50:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNX5GBInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-12-2020 16:50:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BNX5GBInitial Entry
5.c
Date Location User Value Reason
Oct-12-2020 16:50:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKSCMKInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-12-2020 16:50:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BKSCMKInitial Entry
5.d
Date Location User Value Reason
Oct-12-2020 16:50:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKSCMLInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-12-2020 16:50:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BKSCMLInitial Entry
5.e
Date Location User Value Reason
Oct-12-2020 16:50:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKSCMMInitial Entry
090177e196ae3f84\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961538
Page 165 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.e Sample ID
Date Location User Value Reason
Oct-12-2020 16:50:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
BKSCMMInitial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961539
Page 166 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/15/2020Form: 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: 10841266 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-24-2020 18:20:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0961540
Page 167 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/15/2020Form: 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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Assessments
Date Location User Value Reason
Sep-24-2020 18:20:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-24-2020 18:20:23
(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.
Sep-24-2020 18:20:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961541
Page 168 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/15/2020Form: 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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Contact Type:
Date Location User Value Reason
Sep-24-2020 18:20:37
(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
Sep-24-2020 18:20:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Sep/15/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIG
ATOR DECISIONInitial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961542
Page 169 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Oct/13/2020Form: 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: 10841266 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 16:46:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961543
Page 170 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Oct/13/2020Form: 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: 10841266 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 16:46:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 16:46:14
(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 16:46:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961544
Page 171 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Oct/13/2020Form: 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: 10841266 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 16:46:28
(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 16:46:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Oct/13/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIG
ATOR DECISIONInitial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961545
Page 172 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 3 - Unscheduled Visit on
Nov/04/2020Form: 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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-23-2020 03:41:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Event recorded in AE CRF
Nov-20-2020 04:43:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2020459195
sepsis(onset
date:11Nov2020)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.
Nov-05-2020 10:24:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/4/2020Initial Entry
090177e196ae3f84\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-2021-5683-0961546
Page 173 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 3 - Unscheduled Visit on
Nov/04/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Assessments
Date Location User Value Reason
Nov-05-2020 10:26:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-05-2020 10:25:09
(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.
Nov-05-2020 10:25:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961547
Page 174 of 247
***Confidential***
Header Text: c4591001
Visit: Unplanned 3 - Unscheduled Visit on
Nov/04/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Contact Type:
Date Location User Value Reason
Nov-05-2020 10:26:31
(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
Nov-05-2020 10:26:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
If No, why?
Answering machine full, subject did n
ot answer 2 callsInitial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961548
Page 175 of 247
***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, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 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-12-2020 14:37:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-12-2020 14:37:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-12-2020 14:37:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961549
Page 176 of 247
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 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
Feb-01-2021 20:54:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-26-2021 15:10:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Jan-26-2021 15:10:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/12/2021Initial Entry
Jan-21-2021 13:04:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical Please
complete Disposition
Followup, as subject
has died
2. Phase of Disposition:
Date Location User Value Reason
Jan-26-2021 15:10:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Feb-09-2021 17:51:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-04-2021 11:58:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered the field will query if
you put specify
status...correct as is
Feb-04-2021 11:58:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Feb-04-2021 11:57:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Response to "Status" is
DEATH but "Specify
Status" is Provided.
Jan-27-2021 18:20:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened ClinQuery: Disposition
Follow-up status =
'Death'. Please ensure
'Specify Status' field is
populated. Thank you.
090177e196ae3f84\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-2021-5683-0961550
Page 177 of 247
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Jan-26-2021 15:10:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DEATHInitial Entry
4. Specify Status:
Date Location User Value Reason
Feb-04-2021 11:58:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Feb-04-2021 11:57:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
DeathInitial Entry
090177e196ae3f84\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-2021-5683-0961551
Page 178 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Nov-20-2020 16:57:28
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961552
Page 179 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Nov-20-2020 16:59:06
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961553
Page 180 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Nov-20-2020 17:00:16
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961554
Page 181 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Nov-20-2020 17:01:28
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961555
Page 182 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Nov-30-2020 09:46:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961556
Page 183 of 247
***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: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Dec-03-2020 16:19:18
(UTC-06:00) Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f84\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961557
Page 184 of 247
***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, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Nov-20-2020 16:57:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-20-2020 16:57:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-01-2021
07:00:04
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 7: Clos
edResponse satisfies query
Feb-26-2021
13:28:51
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 7: Ans
weredIt is unknown because the
subject does not have family
and the medical records do not
indicate an autopsy- one may
have been done but we will
never no- unknown is more
accurate
Feb-26-2021
08:11:53
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 7: Reis
sued:OpenedClinical Thank you; however,
the 25Feb 21 SAE update still
records Autopsy (in Death
details section) as UNKNOWN
rather than NONE
Feb-25-2021
13:16:37
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 7: Ans
weredSAE report sent
Feb-25-2021
07:14:01
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 7: Reis
sued:OpenedClinical Thank you; please
submit this important
information to the SAE report
Feb-24-2021 ACV0PFEINFP6000 Query 7: Ans No record of transfer for
090177e196ae3f84\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-2021-5683-0961558
Page 185 of 247
***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, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
08:24:13
(UTC-06:00)
Central Time
(US & Canada)wered autopsy
Feb-10-2021
17:30:50
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 7: Ope
nedClinical Please clarify if
autopsy performed; with
subject discharged to SNF, is
there any record of transfer to
Medical Examiner or hospital
pathology department for an
autopsy.
Feb-10-2021
17:19:51
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 6: Clos
edno issue / clarified with med
writer
Feb-04-2021
16:20:17
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 6: Ans
weredplease indicate which page this
is documented on
Feb-02-2021
23:10:48
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 6: Ope
nedClinical Please clarify
statement in SAE report which
reports 'New prescriptions on
discharge'
Dec-03-2020
09:09:04
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 5: Clos
edResponse satisfies query
Dec-02-2020
17:18:52
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 5: Ans
weredPer PI NSTEMI is not an SAE
Dec-01-2020
16:20:45
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 5: Ope
nedCLINICAL SAE narrative
reports subject experienced a
NSTEMI in Hosp, documented
by elevated troponin values;
however not recorded on CRF.
As NSTEMI occurred after
Visit 3, report this event only if
Serious.
Dec-01-2020
16:19:22
(UTC-06:00)
Central TimeACV0PFEINFP6000 Query 3: Clos
edwill reword to include
post-visit 3 language (only
SAEs are reported)
090177e196ae3f84\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), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961559
Page 186 of 247
***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, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(US & Canada)
Dec-01-2020
15:26:21
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Reis
sued:OpenedCLINICAL SAE narrative
reports that subject
experienced a NSTEMI in
hospital, documented by
elevated troponin values;
however to AE / SAE is
recorded on the AE log CRF.
Please review for safety
significance, and update as
appropriate.
Dec-01-2020
05:54:57
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 4: Clos
edResponse satisfies query
Nov-30-2020
11:03:47
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 1: Clos
edDiscrepancy has been closed.
Nov-30-2020
09:42:53
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Ans
weredTranscription Error
Nov-30-2020
09:42:53
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Ans
weredTranscription Error
Nov-30-2020
09:42:53
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Ans
weredTranscription Error
Nov-30-2020
09:42:53
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Acute Emphy
sematous Cho
lecystitisTranscription Error
Nov-25-2020
03:17:19
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 4: Ope
nedSAE
RECON:AER#2020459195,the
term in Safety database was
reported separately as 'acute
emphysematous cholecystitis'
and 'sepsis'.Please verify and
consider tp split the term in AE
090177e196ae3f84\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)
FDA-CBER-2021-5683-0961560
Page 187 of 247
***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, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
CRF. Also, please provide
additional details on sepsis in
Safety database.
Nov-23-2020
18:48:14
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Ope
nedCLINICAL SAE narrative
reports that subject
experienced a NSTEMI in
hospital, documented by
elevated troponin values;
however to AE / SAE is
recorded on the AE log CRF.
Please review for safety
significance, and update as
appropriate.
Nov-23-2020
18:09:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Clos
edResponse satisfies query
Nov-23-2020
15:00:42
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Ans
weredEmergency contact
inadvertently reported this
information which was
incorrect, please see SAE
follow up reports
Nov-21-2020
17:47:21
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Ope
nedCLINICAL SAE narrative
states 'Subject was admitted to
Hosp for routine surgery, and
then became septic). Please
submit information on the
condition & routine surgery
which was planned &
prompted admission.
Nov-21-2020
02:47:51
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle Query 1: Ope
nedMultiple concepts in the term
SEPSIS SECONDARY TO
ACUTE EMPHYSEMATOUS
CHOLECYSTITIS. Split the
term into SEPSIS and ACUTE
EMPHYSEMATOUS
CHOLECYSTITIS and report
as 2 separate entries. Thank
you.
Nov-20-2020
16:57:28
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sepsis Secon
dary to Acute
Emphysemat
ous Cholecyst
itisInitial Entry
4. Start Date Time:
090177e196ae3f84\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-2021-5683-0961561
Page 188 of 247
***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, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Nov-23-2020 18:08:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-23-2020 15:01:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answered This has been updated
in following reports
Nov-21-2020 17:42:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL Event start
date is 03Nov2020;
however, SAE report
has ??Nov 2020. Please
review, harmonize
reporting, and update in
the appropriate location
Nov-20-2020 16:57:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/3/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-28-2021 10:12:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-26-2021 15:00:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Jan-26-2021 15:00:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/12/2021 UNK:UNKNew Information
Jan-23-2021 15:19:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - SAE is no
longer ONGOING,
based on FATAL status.
Please update 'Is AE
still ongoing'?
Nov-20-2020 16:57:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-24-2021 17:17:11
(UTC-06:00) Central TimeACV0PFEINFP6000 Query 1: Closed Response satisfies query
090177e196ae3f84\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),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0961562
Page 189 of 247
***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, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841266 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(US & Canada)
Feb-24-2021 08:24:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Feb-24-2021 08:24:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
4New Information
Feb-09-2021 13:44:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY: please
clarify if the toxicity
grade for Acute
Emphysematous
Cholecystitis should be
reported as 4 (protocol
10.3.3
LIFE-THREATENING:
Life-threatening
consequences; urgent
intervention indicated).
Nov-20-2020 16:57:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial 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/s
…[truncated]