Document text
Page 1 of 361
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
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: 10841470 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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961778
Page 2 of 361
***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: 10841470 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
Sep/30/2020
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961779
Page 3 of 361
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10841470]
2.Birth Date: /1955
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961780
Page 4 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961781
Page 5 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
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? Not Applicable Comments
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? Not Applicable Comments
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? Not Applicable Comments
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? Not Applicable Comments
Criterion ID: (For Pfizer use only) IN04A00
Exclusion Criteria
2.aExclusion Number: 1
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961782
Page 6 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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? Not Applicable Comments
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? Not Applicable Comments
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or
severe allergic reaction (eg, anaphylaxis) to any component of the study
intervention(s)
Criterion met? Not Applicable Comments
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? Not Applicable Comments
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? Not Applicable Comments
Criterion ID: (For Pfizer use only) EX08A00
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961783
Page 7 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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? Not Applicable Comments
Criterion ID: (For Pfizer use only) EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? Not Applicable Comments
Criterion ID: (For Pfizer use only) EX11A00
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? Not Applicable Comments
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? Not Applicable Comments
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days
before study intervention administration or planned receipt throughout
the study
Criterion met? Not Applicable Comments
Criterion ID: (For Pfizer use only) EX14A01
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961784
Page 8 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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? Not Applicable Comments
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? Not Applicable Comments
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? Not Applicable Comments
Criterion ID: (For Pfizer use only) EX21A01
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961785
Page 9 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961786
Page 10 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/30/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961787
Page 11 of 361
***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: 10841470 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:[pulmonary fibrosis]
Start Date: UNK/UNK/2014
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gerd]
Start Date: UNK/UNK/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[insomnia]
Start Date: UNK/UNK/2010
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hyperlipidemia]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961788
Page 12 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What is
the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961789
Page 13 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Sep/30/2020
2.Weight: [130.4]
3.Unit: kg
4.Height: [177.8]
5.Unit: cm
6.Body Mass Index: [41.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961790
Page 14 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/30/2020
2.Randomization Number: [266398]
3.Randomization Group: [ ]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961791
Page 15 of 361
***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: 10841470 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:
Sep/30/2020
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 [BP8PPG]
5.bSample ID [BP8PPH]
5.cSample ID [BP8PPJ]
5.dSample ID [BKZ9LP]
5.eSample ID [BKZ9LR]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961792
Page 16 of 361
***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: 10841470 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/30/2020
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 [BP8PP1]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961793
Page 17 of 361
***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: 10841470 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/30/2020 09:54
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
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961794
Page 18 of 361
***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: 10841470 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
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961795
Page 19 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961796
Page 20 of 361
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Oct/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961797
Page 21 of 361
***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: 10841470 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:
Oct/21/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPC0YD]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961798
Page 22 of 361
***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: 10841470 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: Oct/21/2020 15:53
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
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961799
Page 23 of 361
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L 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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/18/2020
2.Erroneous Visit
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961800
Page 24 of 361
***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, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 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:
Nov/18/2020
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 [BMNDLG]
5.bSample ID [BMNDLH]
5.cSample ID [BKSCXK]
5.dSample ID [BKSCXL]
5.eSample ID [BKSCXM]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961801
Page 25 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961802
Page 26 of 361
***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: 10841470 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 [ ]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961803
Page 27 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961804
Page 28 of 361
***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: 10841470 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 [ ]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961805
Page 29 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961806
Page 30 of 361
***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: 10841470 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 [ ]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961807
Page 31 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: DATE OF VISIT - ILLNESS ONSET
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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961808
Page 32 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/6/2021
2.Date of First Symptom Started: Dec/28/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/11/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961809
Page 33 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.aSymptoms - Other Text: [fatigue]
5.bSymptoms - Other Text: [weakness]
5.cSymptoms - Other Text: [nausea]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961810
Page 34 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date of Co
llectionSpecimen Typ
eSpecimen Collect
ion LocationAssay Code and Description Device TypeForm Instan
ce
1.Dec/31/20
20 SWABBED M
ATERIAL NASOPHARYNX
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961811
Page 35 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/31/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT UNKNOWN]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961812
Page 36 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 10841470 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_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Subject is hospitalized on ventilator]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961813
Page 37 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
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: 10841470 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Subject is hospitalized on ventilator]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961814
Page 38 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
YES
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961815
Page 39 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
1.HOSPITALIZATION STATUS HOSPITAL Dec/31/2020 NO
Discharge Date:
Jan/11/2021
Repeating Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961816
Page 40 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Dec/31/2020
4.Ongoing? NO
Discharge Date:
Jan/11/2021
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961817
Page 41 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatment TreatmentStart D
ateForm Instanc
e
1.1 YES MECHANICAL VENT
ILATION MECHANICAL VENT
ILATION Jan/2/2
021 Repeating
Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961818
Page 42 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1]
2.Concomitant Non-drug Treatment
Pre-specified:YES
3.Treatment: MECHANICAL VENTILATION
4.Treatment: [MECHANICAL VENTILATION]
5.Start Date: Jan/2/2021
6.Ongoing? NO
End Date:
Jan/11/2021
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961819
Page 43 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19]
Date of Diagnosis:
Dec/31/2020
3.Toxicity Grade: 5
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961820
Page 44 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category of Clinical Eve
nt:Subcategory of Clinical EventDiagnosis Obtaine
dToxicity Gr
adeForm Instance
1.SEVERE COVID-19 ILL
NESS SIGNIFICANT ACUTE RENAL DYSFU
NCTION YES
Diagnosis:
Acute Renal Fail
ure
Start Date:
Jan/4/2021
Ongoing?:
NO
End Date:
Jan/11/2021
4 Repeating
Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961821
Page 45 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Illness Details
1.Category of Clinical Event: SEVERE COVID-19 ILLNESS
2.Subcategory of Clinical Event: SIGNIFICANT ACUTE RENAL DYSFUNCTION
3.Was a diagnosis obtained? YES
Diagnosis:
[Acute Renal Failure]
Start Date:
Jan/4/2021
Ongoing?:
NO
End Date:
Jan/11/2021
4.Toxicity Grade: 4
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961822
Page 46 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category for
Lab TestVendor NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1.CLINICAL C
HEMISTRY Methodist Specialty T
ransplant Hospital
8026 Floyd Curl Dr
San Antonio, TX 782
29 Dec/31/2
020 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
329 C Reactive Protein
_PX329 191.
2
30 Alanine Aminotran
sferase_PX30 [ ]
28 Aspartate Aminotr
ansferase_PX28 [ ]
35 Alkaline Phosphat
ase_PX35 51
21 Bilirubin_PX21 .8
47 Blood Urea Nitrog
en_PX47 15
48 Creatinine_PX48 1.10
Repeating
Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961823
Page 47 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Methodist Specialty Transplant Hospital
8026 Floyd Curl Dr
San Antonio, TX 78229]
3.Collection Date: Dec/31/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [191.2]
Not Done:
LNMT Low
[ ]
High
[10]
Unit
mg/dL
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961824
Page 48 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [51]
Not Done:
LNMT Low
[38]
High
[126]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [.8]
Not Done:
LNMT Low
[.2]
High
[1.3]
Unit
mg/dL
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961825
Page 49 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [15]
Not Done:
LNMT Low
[9]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.10]
Not Done:
LNMT Low
[.4]
High
[1.2]
Unit
mg/dL
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961826
Page 50 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category for
Lab TestVendor Name (DERIV
ED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
1.HEMATOLO
GY Methodist Specialty Tra
nsplant Hospital
8026 Floyd Curl Dr
San Antonio, TX 78229
Dec/31/20
20 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
1 Hemoglobin
_PX1 17.8
2 Hematocrit_
PX2 53.1
3 Erythrocytes
_PX3 [ ]
5 Platelets_PX
5 176
7 Leukocytes_
PX7 [ ]
608 Neutrophils_
PX608 [ ]
609 Eosinophils_
PX609 [ ]
612 Monocytes_
PX612 [ ]
610 Basophils_P
X610 [ ]
611 Lymphocytes
_PX611 [ ] Repeating
Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961827
Page 51 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Methodist Specialty Transplant Hospital
8026 Floyd Curl Dr
San Antonio, TX 78229]
3.Collection Date: Dec/31/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [17.8]
Not Done:
LNMT Low
[13]
High
[17]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [53.1]
Not Done:
LNMT Low
[40]
High
[50]
Unit
%
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961828
Page 52 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [176]
Not Done:
LNMT Low
[150]
High
[400]
Unit
/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961829
Page 53 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961830
Page 54 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961831
Page 55 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
1.Jan/11/2021 Record Identifier: Systolic: Diastolic:
1 90 54 Repeating Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961832
Page 56 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
2. DELETED Dec/31/2020 Record Identifier: Systolic: Diastolic:
1 152 88 Repeating Pages
3. Dec/31/2020 Record Identifier: Systolic: Diastolic:
1 171 94 Repeating Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961833
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/11/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [90]
Diastolic: [54]
Respiratory Rate in
respirations/minute:[21]
Heart Rate in beats/minute: [132]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961834
Page 58 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Deleted, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/31/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [152]
Diastolic: [88]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [81]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961835
Page 59 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: VITAL SIGNS - COVID
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/31/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [171]
Diastolic: [94]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [84]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961836
Page 60 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
1. DELETED Dec/31/2020 Record Identifier: Oxygen Saturation
1 92.0 Repeating Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961837
Page 61 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
2. DELETED Dec/31/2020 Record Identifier: Oxygen Saturation
1 93.0 Repeating Pages
3. Dec/31/2020 Record Identifier: Oxygen Saturation
1 88.0 Repeating Pages
4. Jan/4/2021 Record Identifier: Oxygen Saturation
1 95.0 Repeating Pages
5. Jan/11/2021 Record Identifier: Oxygen Saturation
1 96.0 Repeating Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961838
Page 62 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Deleted, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/31/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [92.0]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961839
Page 63 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Deleted, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/31/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [93.0]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961840
Page 64 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/31/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [88.0]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961841
Page 65 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/4/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [95.0]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961842
Page 66 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 14-Jan-2021 02:17 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/11/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [96.0]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961843
Page 67 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Jan/2/2021 17:42 40 0.84 Repeating Pages
2.Jan/11/2021 07:45 40 0.50 Repeating Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961844
Page 68 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Oxygenation Parameters
1.Date Time of Assessment: Jan/2/2021 17:42
2.Arterial Blood Gases PaO2 (mmHg): [40]
3.FiO2 (Fraction of Inhaled Oxygen): [0.84]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961845
Page 69 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Oxygenation Parameters
1.Date Time of Assessment: Jan/11/2021 07:45
2.Arterial Blood Gases PaO2 (mmHg): [40]
3.FiO2 (Fraction of Inhaled Oxygen): [0.50]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961846
Page 70 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961847
Page 71 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 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.Start Date: //
6.Ongoing?
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961848
Page 72 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date of Assessmen
tLocation of Assessmen
tImaging Metho
dOverall Assessment Form Instance
1.Dec/31/2020 CHEST X-RAY ABNORMAL
If abnormal, specify findings:
bilateral multifocal viral pneumoni
a
Repeating Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961849
Page 73 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Dec/31/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[bilateral multifocal viral pneumonia]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961850
Page 74 of 361
***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: 10841470 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:
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961851
Page 75 of 361
***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: 10841470 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 [ ]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961852
Page 76 of 361
***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: 10841470 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:
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961853
Page 77 of 361
***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: 10841470 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 [ ]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961854
Page 78 of 361
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961855
Page 79 of 361
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Unplanned Assessments
1.Assessments
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961856
Page 80 of 361
***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: 10841470 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 EV
ENT 1 COVID-19 Infection Dec/31/2020 UNK:
UNK NO
End Date Time:
Jan/11/2021 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Mutli-system organ f
ailure Dec/31/2020 UNK:
UNK NO
End Date Time:
Jan/11/2021 UNK:UNK
Repeating
Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961857
Page 81 of 361
***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: 10841470 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)[COVID-19 Infection]
4.Start Date Time: Dec/31/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/11/2021 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:
[COVID-19]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961858
Page 82 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?: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[2021011324]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961859
Page 83 of 361
***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: 10841470 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)[Mutli-system organ failure]
4.Start Date Time: Dec/31/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/11/2021 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:
[COVID-19]
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(b) (4)
FDA-CBER-2021-5683-0961860
Page 84 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021011324]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961861
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***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961862
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***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: 10841470 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[ ]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961863
Page 87 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of MedicationStart Da
teForm Instanc
e
1.1 VACCINATIONS
NO MODERNA COVID 19
VACCINE Dec/23/2
020 Repeating
Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961864
Page 88 of 361
***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: 10841470 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).[MODERNA COVID 19 VACCINE]
5.Date: Dec/23/2020
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961865
Page 89 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medica
tionDose Descri
ptionForm Instanc
e
1.1 IMMUNOGLOBU
LINS NO Monoclonal Anti
bodies Unknown Repeating
Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961866
Page 90 of 361
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 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: IMMUNOGLOBULINS
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).[Monoclonal Antibodies]
5.Dose: Unknown
[ ]Comments
6.Dose Unit: Unknown Comments
7.Dose Frequency: Unknown Comments
8.Route: Unknown Comments
9.Start Date: Dec/31/2020
10.Ongoing? NO
End Date:
Dec/31/2020
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961867
Page 91 of 361
***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: 10841470 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
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961868
Page 92 of 361
***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: 10841470 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?
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961869
Page 93 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961870
Page 94 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961871
Page 95 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/18/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961872
Page 96 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961873
Page 97 of 361
***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: 10841470 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:
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961874
Page 98 of 361
***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: 10841470 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?
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961875
Page 99 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961876
Page 100 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961877
Page 101 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961878
Page 102 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961879
Page 103 of 361
***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: 10841470 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 [ ]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961880
Page 104 of 361
***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: 10841470 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 [ ]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961881
Page 105 of 361
***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: 10841470 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/11/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961882
Page 106 of 361
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021 Comments
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961883
Page 107 of 361
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 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
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961884
Page 108 of 361
***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: 10841470 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
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961885
Page 109 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961886
Page 110 of 361
***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: 10841470 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/19/2021
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Multi-system organ failure]
2.bCause of Death Status: SECONDARY CAUSE OF DEATH
Cause of Death: [COVID-19]
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961887
Page 111 of 361
***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: 10841470 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/11/2021
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961888
Page 112 of 361
***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: 10841470 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
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961889
Page 113 of 361
***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: 10841470 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
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961890
Page 114 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961891
Page 115 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.aJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961892
Page 116 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.bJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961893
Page 117 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.cJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961894
Page 118 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1.dJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961895
Page 119 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.aJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961896
Page 120 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.bJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961897
Page 121 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.cJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961898
Page 122 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.dJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961899
Page 123 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.eJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961900
Page 124 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.fJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961901
Page 125 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.gJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961902
Page 126 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.hJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961903
Page 127 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.iJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961904
Page 128 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.jJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961905
Page 129 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.kJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961906
Page 130 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.lJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961907
Page 131 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.mJan-21-2021 16:19:21 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961908
Page 132 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormJan-21-2021 16:19:41 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961909
Page 133 of 361
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Feb-22-2021 17:15:13 (UTC-06:00) Central Time
(US & Canada)Unknown
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961910
Page 134 of 361
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Feb-08-2021 14:13:11 (UTC-06:00) Central Time
(US & Canada)Unknown
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0961911
Page 135 of 361
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
7Feb-22-2021 17:15:25 (UTC-06:00) Central Time
(US & Canada)Unknown
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961912
Page 136 of 361
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
8Feb-08-2021 14:13:27 (UTC-06:00) Central Time
(US & Canada)Unknown
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0961913
Page 137 of 361
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact 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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-04-2021 16:53:16 (UTC-06:00) Central Time
(US & Canada)not done
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961914
Page 138 of 361
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: 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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-04-2021 16:52:34 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961915
Page 139 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-04-2021 16:52:34 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961916
Page 140 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-08-2021 16:03:25 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961917
Page 141 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-08-2021 16:03:25 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961918
Page 142 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Mar-08-2021 16:03:25 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961919
Page 143 of 361
***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: 10841470 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 10:22:43 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-22-2021 18:18:17 (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-18-2020 15:50:02 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-11-2020 15:07:14 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961920
Page 144 of 361
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 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
Jan-21-2021 16:18:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Transcription Error
Sep-30-2020 10:54:50
(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
Sep-30-2020 10:54:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f85\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-2021-5683-0961921
Page 145 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-30-2020 10:54:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/30/2020Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961922
Page 146 of 361
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-30-2020 10:54:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10841470Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-30-2020 10:54:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1955Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-30-2020 10:55:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-30-2020 10:55:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-30-2020 10:55:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3f85\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-2021-5683-0961923
Page 147 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-30-2020 10:56:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961924
Page 148 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion De
scripti
on:Male or female participant
s between the ages of 18 a
nd 55 years, inclusive, 65
and 85 years, inclusive, or
18 and 85 years, inclusive,
at randomization (depende
nt upon study stage)
Criter
ion m
et?:Not Applicable
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion De
scripti
on:Male or female participant
s between the ages of 18 a
nd 55 years, inclusive, 65
and 85 years, inclusive, or
18 and 85 years, inclusive,
at randomization (depende
nt upon study stage)
Criter
ion m
et?:Transcription Error
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961925
Page 149 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion De
scripti
on:Male or female participant
s between the ages of 18 a
nd 55 years, inclusive, 65
and 85 years, inclusive, or
18 and 85 years, inclusive,
at randomization (depende
nt upon study stage)
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Male or female participants between
the ages of 18 and 55 years, inclusiv
e, 65 and 85 years, inclusive, or 18 a
nd 85 years, inclusive, at randomizat
ion (dependent upon study stage)Initial Entry
1.a Criterion met?
090177e196ae3f85\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-2021-5683-0961926
Page 150 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willi
ng and able to comply wit
h all scheduled visits, vac
cination plan, laboratory t
ests, lifestyle consideratio
ns, and other study proce
dures
Criteri
on met
?:Not Applicable
Criteri
on ID:
(For P
fizer u
se only
):IN02A00Initial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu2Transcription Error
090177e196ae3f85\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-2021-5683-0961927
Page 151 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
mber:
Criteri
on Des
criptio
n:Participants who are willi
ng and able to comply wit
h all scheduled visits, vac
cination plan, laboratory t
ests, lifestyle consideratio
ns, and other study proce
dures
Criteri
on met
?:
Criteri
on ID:
(For P
fizer u
se only
):IN02A00
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willi
ng and able to comply wit
h all scheduled visits, vac
cination plan, laboratory t
ests, lifestyle consideratio
ns, and other study proce
dures
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN02A00Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961928
Page 152 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.b Inclusion Number:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participants who are willing and abl
e to comply with all scheduled visits
, vaccination plan, laboratory tests, l
ifestyle considerations, and other stu
dy proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 10:56:31
(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
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae3f85\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-2021-5683-0961929
Page 153 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Healthy participants who
are determined by medica
l history, physical examin
ation, and clinical judgme
nt of the investigator to b
e eligible for inclusion in
the study
Criteri
on met
?:Not Applicable
Criteri
on ID:
(For P
fizer u
se only
):IN03A00
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who
are determined by medica
l history, physical examin
ation, and clinical judgme
nt of the investigator to b
e eligible for inclusion in
the study
Criteri
on met
?:
Criteri
on ID:
(For P
fizer u
se only
):IN03A00Transcription Error
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961930
Page 154 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Healthy participants who
are determined by medica
l history, physical examin
ation, and clinical judgme
nt of the investigator to b
e eligible for inclusion in
the study
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN03A00
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961931
Page 155 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.c Inclusion Number:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Healthy participants who are determ
ined by medical history, physical ex
amination, and clinical judgment of
the investigator to be eligible for inc
lusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 10:56:31
(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
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae3f85\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-2021-5683-0961932
Page 156 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Capable of giving person
al signed informed conse
nt, which includes compli
ance with the requirement
s and restrictions listed in
the ICD and in this protoc
ol
Criteri
on met
?:Not Applicable
Criteri
on ID:
(For P
fizer u
se only
):IN04A00
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4
Criteri
on Des
criptio
n:Capable of giving person
al signed informed conse
nt, which includes compli
ance with the requirement
s and restrictions listed in
the ICD and in this protoc
ol
Criteri
on met
?:
Criteri
on ID:
(For P
fizer u
se only
):IN04A00Transcription Error
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961933
Page 157 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Capable of giving person
al signed informed conse
nt, which includes compli
ance with the requirement
s and restrictions listed in
the ICD and in this protoc
ol
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN04A00
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961934
Page 158 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.d Inclusion Number:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Capable of giving personal signed in
formed consent, which includes com
pliance with the requirements and re
strictions listed in the ICD and in thi
s protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 10:56:31
(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
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:1Initial Entry
090177e196ae3f85\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-2021-5683-0961935
Page 159 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criter
ion De
scripti
on:Other medical or psychiat
ric condition incl. recent (
within past year) or active
suicidal ideation/behavior
/lab abnormality that may
increase the risk of study
participation
Criter
ion me
t?:Not Applicable
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:1
Criter
ion De
scripti
on:Other medical or psychiat
ric condition incl. recent (
within past year) or active
suicidal ideation/behavior
/lab abnormality that may
increase the risk of study
participation
Criter
ion me
t?:
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00Transcription Error
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:1Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961936
Page 160 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criter
ion De
scripti
on:Other medical or psychiat
ric condition incl. recent (
within past year) or active
suicidal ideation/behavior
/lab abnormality that may
increase the risk of study
participation
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Other medical or psychiatric conditi
on incl. recent (within past year) or
active suicidal ideation/behavior/lab
abnormality that may increase the ri
sk of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 10:56:31
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f85\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-2021-5683-0961937
Page 161 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Time (US & Canada)
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with h
uman immunodeficienc
y virus (HIV), hepatitis
C virus (HCV), or hepat
itis B virus (HBV)
Criterio
n met?:Not Applicable
Criterio
n ID: (F
or Pfize
r use onl
y):EX02A00Initial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with h
uman immunodeficienc
y virus (HIV), hepatitis
C virus (HCV), or hepat
itis B virus (HBV)
Criterio
n met?:
Criterio
n ID: (F
or Pfize
r use onl
y):EX02A00Transcription Error
090177e196ae3f85\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-2021-5683-0961938
Page 162 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with h
uman immunodeficienc
y virus (HIV), hepatitis
C virus (HCV), or hepat
itis B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX02A00Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961939
Page 163 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.b Exclusion Number:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Known infection with human immu
nodeficiency virus (HIV), hepatitis
C virus (HCV), or hepatitis B virus (
HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 10:56:31
(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
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196ae3f85\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-2021-5683-0961940
Page 164 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:History of severe adverse
reaction associated with a
vaccine and/or severe alle
rgic reaction (eg, anaphyl
axis) to any component o
f the study intervention(s)
Criteri
on met
?:Not Applicable
Criteri
on ID:
(For P
fizer u
se only
):EX03A00
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:3
Criteri
on Des
criptio
n:History of severe adverse
reaction associated with a
vaccine and/or severe alle
rgic reaction (eg, anaphyl
axis) to any component o
f the study intervention(s)
Criteri
on met
?:
Criteri
on ID:
(For P
fizer u
se only
):EX03A00Transcription Error
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:3
Criteri
on Des
criptio
n:History of severe adverse
reaction associated with a
vaccine and/or severe alle
rgic reaction (eg, anaphyl
axis) to any component o
f the study intervention(s)Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961941
Page 165 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX03A00
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961942
Page 166 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.c Exclusion Number:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
History of severe adverse reaction a
ssociated with a vaccine and/or seve
re allergic reaction (eg, anaphylaxis)
to any component of the study inter
vention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 10:56:31
(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
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion N
umber:4Initial Entry
090177e196ae3f85\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-2021-5683-0961943
Page 167 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterion De
scription:Receipt of medicati
ons intended to pre
vent COVID-19
Criterion me
t?:Not Applicable
Criterion ID
: (For Pfizer
use only):EX04A00
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion N
umber:4
Criterion De
scription:Receipt of medicati
ons intended to pre
vent COVID-19
Criterion me
t?:
Criterion ID
: (For Pfizer
use only):EX04A00Transcription Error
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion N
umber:4
Criterion De
scription:Receipt of medicati
ons intended to pre
vent COVID-19
Criterion me
t?:NO
Criterion ID
: (For Pfizer
use only):EX04A00Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961944
Page 168 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.d Exclusion Number:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of medications intended to p
revent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 10:56:31
(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
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:8Initial Entry
090177e196ae3f85\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-2021-5683-0961945
Page 169 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Immunocompromised in
dividuals with known or
suspected immunodeficie
ncy, as determined by his
tory and/or laboratory/ph
ysical examination
Criteri
on met
?:Not Applicable
Criteri
on ID:
(For Pf
izer us
e only):EX08A00
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:8
Criteri
on Des
criptio
n:Immunocompromised in
dividuals with known or
suspected immunodeficie
ncy, as determined by his
tory and/or laboratory/ph
ysical examination
Criteri
on met
?:
Criteri
on ID:
(For Pf
izer us
e only):EX08A00Transcription Error
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:8
Criteri
on Des
criptio
n:Immunocompromised in
dividuals with known or
suspected immunodeficie
ncy, as determined by his
tory and/or laboratory/ph
ysical examination
Criteri
on met
?:NOInitial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961946
Page 170 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on ID:
(For Pf
izer us
e only):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Immunocompromised individuals w
ith known or suspected immunodefi
ciency, as determined by history and
/or laboratory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 10:56:31
(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
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
090177e196ae3f85\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-2021-5683-0961947
Page 171 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:10
Criteri
on Des
criptio
n:Bleeding diathesis or con
dition associated with pro
longed bleeding that wou
ld, in the opinion of the i
nvestigator, contraindicat
e intramuscular injection
Criteri
on met
?:Not Applicable
Criteri
on ID:
(For Pf
izer us
e only)
:EX10A00Initial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:10
Criteri
on Des
criptio
n:Bleeding diathesis or con
dition associated with pro
longed bleeding that wou
ld, in the opinion of the i
nvestigator, contraindicat
e intramuscular injection
Criteri
on met
?:
Criteri
on ID:
(For Pf
izer us
e only)
:EX10A00Transcription Error
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:10Initial Entry
090177e196ae3f85\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-2021-5683-0961948
Page 172 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Bleeding diathesis or con
dition associated with pro
longed bleeding that wou
ld, in the opinion of the i
nvestigator, contraindicat
e intramuscular injection
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition asso
ciated with prolonged bleeding that
would, in the opinion of the investig
ator, contraindicate intramuscular in
jectionInitial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961949
Page 173 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
2.f Criterion met?
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 10:56:31
(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
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:11
Criterion Desc
ription:Women who are
pregnant or breas
tfeeding
Criterion met
?:Not Applicable
Criterion ID: (
For Pfizer use
only):EX11A00Initial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:11
Criterion Desc
ription:Women who are
pregnant or breas
tfeeding
Criterion met
?:Transcription Error
090177e196ae3f85\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-2021-5683-0961950
Page 174 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterion ID: (
For Pfizer use
only):EX11A00
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:11
Criterion Desc
ription:Women who are
pregnant or breas
tfeeding
Criterion met
?:NO
Criterion ID: (
For Pfizer use
only):EX11A00Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961951
Page 175 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.g Exclusion Number:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Women who are pregnant or breastf
eedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 10:56:31
(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
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinati
on with any coron
avirus vaccineInitial Entry
090177e196ae3f85\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-2021-5683-0961952
Page 176 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterion me
t?:Not Applicable
Criterion ID:
(For Pfizer u
se only):EX12A00
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinati
on with any coron
avirus vaccine
Criterion me
t?:
Criterion ID:
(For Pfizer u
se only):EX12A00Transcription Error
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinati
on with any coron
avirus vaccine
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX12A00Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961953
Page 177 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.h Exclusion Number:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Previous vaccination with any coron
avirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 10:56:31
(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
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:13Initial Entry
090177e196ae3f85\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-2021-5683-0961954
Page 178 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterio
n Descri
ption:Subjects who receive i
mmunosuppressive ther
apy, such as cytotoxic a
gents or systemic cortic
osteroids
Criterio
n met?:Not Applicable
Criterio
n ID: (F
or Pfizer
use only)
:EX13A01
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:13
Criterio
n Descri
ption:Subjects who receive i
mmunosuppressive ther
apy, such as cytotoxic a
gents or systemic cortic
osteroids
Criterio
n met?:
Criterio
n ID: (F
or Pfizer
use only)
:EX13A01Transcription Error
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:13
Criterio
n Descri
ption:Subjects who receive i
mmunosuppressive ther
apy, such as cytotoxic a
gents or systemic cortic
osteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX13A01Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961955
Page 179 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.i Exclusion Number:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Subjects who receive immunosuppr
essive therapy, such as cytotoxic age
nts or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 10:56:31
(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
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:15Initial Entry
090177e196ae3f85\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-2021-5683-0961956
Page 180 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Receipt of blood/plasma
products or immunoglob
ulin, from 60 days before
study intervention admini
stration or planned receip
t throughout the study
Criteri
on met
?:Not Applicable
Criteri
on ID:
(For Pf
izer us
e only)
:EX14A01
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:15
Criteri
on Des
criptio
n:Receipt of blood/plasma
products or immunoglob
ulin, from 60 days before
study intervention admini
stration or planned receip
t throughout the study
Criteri
on met
?:
Criteri
on ID:
(For Pf
izer us
e only)
:EX14A01Transcription Error
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:15
Criteri
on Des
criptio
n:Receipt of blood/plasma
products or immunoglob
ulin, from 60 days before
study intervention admini
stration or planned receip
t throughout the studyInitial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961957
Page 181 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX14A01
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961958
Page 182 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.j Exclusion Number:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma products or
immunoglobulin, from 60 days befo
re study intervention administration
or planned receipt throughout the st
udyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 10:56:31
(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
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
2.k
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:16Initial Entry
090177e196ae3f85\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)
(4),
(b) (6)
FDA-CBER-2021-5683-0961959
Page 183 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterio
n Descr
iption:Participation in other stu
dies involving study inte
rvention within 28 days
prior to study entry and/
or during study participa
tion
Criterio
n met?:Not Applicable
Criterio
n ID: (F
or Pfize
r use on
ly):EX15A01
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:16
Criterio
n Descr
iption:Participation in other stu
dies involving study inte
rvention within 28 days
prior to study entry and/
or during study participa
tion
Criterio
n met?:
Criterio
n ID: (F
or Pfize
r use on
ly):EX15A01Transcription Error
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:16
Criterio
n Descr
iption:Participation in other stu
dies involving study inte
rvention within 28 days
prior to study entry and/
or during study participa
tion
Criterio
n met?:NOInitial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961960
Page 184 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterio
n ID: (F
or Pfize
r use on
ly):EX15A01
2.k Exclusion Number:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participation in other studies involvi
ng study intervention within 28 days
prior to study entry and/or during st
udy participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 10:56:31
(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
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
090177e196ae3f85\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-2021-5683-0961961
Page 185 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Jan-21-2021 16:19:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:17
Criterion
Descripti
on:Previous participation i
n other studies involvin
g study intervention co
ntaining lipid nanoparti
cles
Criterion
met?:Not Applicable
Criterion
ID: (For
Pfizer us
e only):EX16A01Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961962
Page 186 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
2.l
Date Location User Value Reason
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:17
Criterion
Descripti
on:Previous participation
in other studies involvi
ng study intervention c
ontaining lipid nanopa
rticles
Criterion
met?:
Criterion
ID: (For
Pfizer us
e only):EX16A01Transcription Error
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:17
Criterion
Descripti
on:Previous participation
in other studies involvi
ng study intervention c
ontaining lipid nanopa
rticles
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX16A01Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961963
Page 187 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.l Exclusion Number:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Previous participation in other studi
es involving study intervention cont
aining lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 10:56:31
(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
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:22Initial Entry
090177e196ae3f85\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-2021-5683-0961964
Page 188 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criter
ion De
scripti
on:Investigator site staff or P
fizer employees directly i
nvolved in the conduct of
the study, site staff otherw
ise supervised by the inve
stigator, and their respecti
ve family members
Criter
ion m
et?:Not Applicable
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:22
Criter
ion De
scripti
on:Investigator site staff or P
fizer employees directly i
nvolved in the conduct of
the study, site staff otherw
ise supervised by the inve
stigator, and their respecti
ve family members
Criter
ion m
et?:
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01Transcription Error
Sep-30-2020 10:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclu
sion N
umbe
r:22Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961965
Page 189 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criter
ion De
scripti
on:Investigator site staff or P
fizer employees directly i
nvolved in the conduct of
the study, site staff otherw
ise supervised by the inve
stigator, and their respecti
ve family members
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961966
Page 190 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.m Exclusion Number:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer empl
oyees directly involved in the condu
ct of the study, site staff otherwise s
upervised by the investigator, and th
eir respective family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Jan-21-2021 16:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-21-2021 16:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Sep-30-2020 10:56:31
(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
Sep-30-2020 10:56:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae3f85\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),
(b) (6)
FDA-CBER-2021-5683-0961967
Page 191 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 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
Sep-30-2020 10:59:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-30-2020 10:59:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-30-2020 10:59:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961968
Page 192 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Sep-30-2020 11:06:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:pulmonary fibr
osis
Start Date: UNK/UNK/201
4
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-30-2020 11:06:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-30-2020 11:06:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
pulmonary fibrosisInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-30-2020 11:06:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-30-2020 11:06:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae3f85\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-2021-5683-0961969
Page 193 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-30-2020 11:06:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:hypertension
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-30-2020 11:06:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-30-2020 11:06:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
hypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-30-2020 11:06:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-30-2020 11:06:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-30-2020 11:17:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:gerdInitial Entry
090177e196ae3f85\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-2021-5683-0961970
Page 194 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Start Date: UNK/UNK/20
10
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-30-2020 11:17:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-30-2020 11:17:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
gerdInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-30-2020 11:17:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-30-2020 11:17:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-30-2020 11:17:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:insomnia
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae3f85\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-2021-5683-0961971
Page 195 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.d Line/MH Number:
Date Location User Value Reason
Sep-30-2020 11:17:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-30-2020 11:17:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
insomniaInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-30-2020 11:17:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-30-2020 11:17:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-30-2020 11:17:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:hyperlipidemia
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae3f85\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-2021-5683-0961972
Page 196 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.e Line/MH Number:
Date Location User Value Reason
Sep-30-2020 11:17:49
(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
Sep-30-2020 11:17:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
hyperlipidemiaInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-30-2020 11:17:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-30-2020 11:17:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f85\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-2021-5683-0961973
Page 197 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Jan-21-2021 16:19:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be HI
V POSITIVEInitial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961974
Page 198 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Sep-30-2020 11:02:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-30-2020 11:02:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
130.4Initial Entry
3. Unit:
Date Location User Value Reason
Sep-30-2020 11:02:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-30-2020 11:02:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
177.8Initial Entry
5. Unit:
Date Location User Value Reason
Sep-30-2020 11:02:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-30-2020 11:02:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
41.2Initial Entry
090177e196ae3f85\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-2021-5683-0961975
Page 199 of 361
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7.a
Date Location User Value Reason
Sep-30-2020 11:02:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.8
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-30-2020 11:02:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-30-2020 11:02:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-30-2020 11:02:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-30-2020 11:02:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f85\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-2021-5683-0961976
Page 200 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-30-2020 11:35:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-30-2020 11:35:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
266398Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961977
Page 201 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020 10:29:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020 10:29:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020 10:30:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-01-2020 10:29:52
(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-01-2020 10:29:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020 10:30:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8PPGInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961978
Page 202 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Oct-01-2020 10:30:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8PPGInitial Entry
5.b
Date Location User Value Reason
Oct-01-2020 10:30:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8PPHInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-01-2020 10:30:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8PPHInitial Entry
5.c
Date Location User Value Reason
Oct-01-2020 10:30:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8PPJInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-01-2020 10:30:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8PPJInitial Entry
5.d
Date Location User Value Reason
Oct-01-2020 10:32:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKZ9LPInitial Entry
090177e196ae3f85\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-2021-5683-0961979
Page 203 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.d Sample ID
Date Location User Value Reason
Oct-01-2020 10:32:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BKZ9LPInitial Entry
5.e
Date Location User Value Reason
Oct-01-2020 10:32:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKZ9LRInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-01-2020 10:32:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BKZ9LRInitial Entry
090177e196ae3f85\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-2021-5683-0961980
Page 204 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020 10:28:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020 10:28:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020 10:29:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-01-2020 10:28:47
(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-01-2020 10:28:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020 10:29:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8PP1Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961981
Page 205 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Oct-01-2020 10:29:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8PP1Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961982
Page 206 of 361
***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: 10841470 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-30-2020 11:03:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-30-2020 11:03:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-30-2020 11:03:39
(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-30-2020 11:03:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020 09:54Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-30-2020 11:03:39
(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-30-2020 11:03:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3f85\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-2021-5683-0961983
Page 207 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7. Route:
Date Location User Value Reason
Sep-30-2020 11:03:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-30-2020 11:03:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-30-2020 11:03:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961984
Page 208 of 361
***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: 10841470 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
Sep-30-2020 11:03:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961985
Page 209 of 361
***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: 10841470 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-21-2020 16:53:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961986
Page 210 of 361
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Oct-21-2020 16:53:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
2.a
Date Location User Value Reason
Oct-21-2020 16:53:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-21-2020 16:53:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-21-2020 16:53:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
36.6Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-21-2020 16:53:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae3f85\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-2021-5683-0961987
Page 211 of 361
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Oct-21-2020 16:53:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961988
Page 212 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 11:00:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 11:00:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 11:00:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 11:00:36
(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-22-2020 11:00:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020 11:00:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPC0YDInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961989
Page 213 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Oct-22-2020 11:00:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPC0YDInitial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961990
Page 214 of 361
***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: 10841470 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
Oct-21-2020 16:54:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-21-2020 16:54:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-21-2020 16:54:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-21-2020 16:54:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020 15:53Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-21-2020 16:54:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-21-2020 16:54:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3f85\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-2021-5683-0961991
Page 215 of 361
***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: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7. Route:
Date Location User Value Reason
Oct-21-2020 16:54:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-21-2020 16:54:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-21-2020 16:54:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961992
Page 216 of 361
***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, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 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-18-2020 15:50:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/18/2020Initial Entry
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961993
Page 217 of 361
***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, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-19-2020 10:05:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-19-2020 10:05:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-19-2020 10:06:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-19-2020 10:05:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Nov-19-2020 10:05:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/18/2020Initial Entry
5.a
Date Location User Value Reason
Nov-19-2020 10:06:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMNDLGInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3f85\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961994
Page 218 of 361
***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, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Nov-19-2020 10:06:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMNDLGInitial Entry
5.b
Date Location User Value Reason
Nov-19-2020 10:06:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMNDLHInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-19-2020 10:06:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMNDLHInitial Entry
5.c
Date Location User Value Reason
Nov-19-2020 10:07:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKSCXKInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-19-2020 10:07:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BKSCXKInitial Entry
5.d
Date Location User Value Reason
Nov-19-2020 10:07:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKSCXLInitial Entry
090177e196ae3f85\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-2021-5683-0961995
Page 219 of 361
***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, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.d Sample ID
Date Location User Value Reason
Nov-19-2020 10:07:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BKSCXLInitial Entry
5.e
Date Location User Value Reason
Nov-19-2020 10:07:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKSCXMInitial Entry
5.e Sample ID
Date Location User Value Reason
Nov-19-2020 10:07:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BKSCXMInitial Entry
090177e196ae3f85\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-2021-5683-0961996
Page 220 of 361
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/06/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841470 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021 01:35:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 5: Closed This issue will put on
Hold in PD tracker
Feb-15-2021 00:03:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 5: Reissued:Candidate PDQ RQ1: Thank
you for the response,
please confirm the
date scheduled in
query response and
requesting to respond
to query once data
available. Else
clarify.
Feb-12-2021 10:32:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 5: Answered subject is recovering
from hospitilization
due to Covid_19.
Convalescent Visit
will not take place
until the subject is
completely
recovered.
Feb-11-2021 05:06:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 5: Opened PDQ: Convalescent
visit is missing and
35+ days (36) have
…[truncated]