Document text
Page 1 of 428
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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 version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
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(b) (4)
FDA-CBER-2021-5683-0962313
Page 2 of 428
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
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: 10841538 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
Nov/6/2020
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962314
Page 3 of 428
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10841538]
2.Birth Date: /2004
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962315
Page 4 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962316
Page 5 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use only) IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use only) IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for inclusion
in the study
Criterion met? YES
Criterion ID: (For Pfizer use only) IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance
with the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use only) IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
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(b) (4)
FDA-CBER-2021-5683-0962317
Page 6 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterion met? NO
Criterion ID: (For Pfizer use only) EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use only) EX08A00
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would, in
the opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use only) EX10A00
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962318
Page 7 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing
lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use only) EX16A01
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962319
Page 8 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members
Criterion met? NO
Criterion ID: (For Pfizer use only) EX21A01
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962320
Page 9 of 428
***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: 10841538 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
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962321
Page 10 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathNov/6/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962322
Page 11 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 10841538 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:[seasonal allergies]
Start Date: UNK/UNK/2009
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[insomnia]
Start Date: UNK/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[post-traumatic stress disorder]
Start Date: UNK/UNK/2015
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[depression]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962323
Page 12 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[kidney infection]
Start Date: Aug/UNK/2010
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tonsillectomy]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tonsillitis]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
Nov/UNK/2006
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anxiety]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962324
Page 13 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[urinary tract infection]
Start Date: Sep/UNK/2010
Ongoing: YES
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962325
Page 14 of 428
***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: 10841538 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
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962326
Page 15 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Nov/6/2020
2.Weight: [79.6]
3.Unit: kg
4.Height: [165.5]
5.Unit: cm
6.Body Mass Index: [29.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962327
Page 16 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/6/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962328
Page 17 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Nov/6/2020
2.Randomization Number: [114554]
3.Randomization Group: [ ]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962329
Page 18 of 428
***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, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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/6/2020
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 [BNX58R]
5.bSample ID [BNX58S]
5.cSample ID [BR037C]
5.dSample ID [BR037D]
5.eSample ID [BR037F]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962330
Page 19 of 428
***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, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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:
Nov/6/2020
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 [BKSCRY]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962331
Page 20 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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: Nov/6/2020 10:57
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
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962332
Page 21 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962333
Page 22 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/30/2020
2.Erroneous Visit
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962334
Page 23 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962335
Page 24 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962336
Page 25 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Nov/30/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962337
Page 26 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/30/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962338
Page 27 of 428
***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, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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:
Nov/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 [BPC22R]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962339
Page 28 of 428
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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: Nov/30/2020 09:56
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
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962340
Page 29 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962341
Page 30 of 428
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962342
Page 31 of 428
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 14-Jan-2021 02:28 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962343
Page 32 of 428
***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: 10841538 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:
Dec/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 [BPC1W5]
5.bSample ID [BPC1W6]
5.cSample ID [BPC1W7]
5.dSample ID [BMNDT7]
5.eSample ID [BMNDT8]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962344
Page 33 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962345
Page 34 of 428
***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: 10841538 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 [ ]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962346
Page 35 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962347
Page 36 of 428
***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: 10841538 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 [ ]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962348
Page 37 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962349
Page 38 of 428
***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: 10841538 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 [ ]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962350
Page 39 of 428
***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: 10841538 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
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962351
Page 40 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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: Jan/2/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/9/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? YES
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? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962352
Page 41 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Symptoms - Other
5.aSymptoms - Other Text: [Nasal congestion]
5.bSymptoms - Other Text: [Chest congestion]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962353
Page 42 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Type Form Instance
1.Not Applicable Not Applicab
le Not Applicable Not Applicable Not Applicab
le Repeating
Pages
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962354
Page 43 of 428
***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, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962355
Page 44 of 428
***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: 10841538 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 swabbed at another facility]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962356
Page 45 of 428
***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: 10841538 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:[Swab collected at another facility]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962357
Page 46 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962358
Page 47 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962359
Page 48 of 428
***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
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962360
Page 49 of 428
***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, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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?NO
3.Toxicity Grade: 2
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962361
Page 50 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable
Repeating Pages
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962362
Page 51 of 428
***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
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962363
Page 52 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Appli
cable Not Applic
able Not Applic
able Sponsor-Defined
IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962364
Page 53 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962365
Page 54 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962366
Page 55 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962367
Page 56 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962368
Page 57 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
1.Not Applicabl
e Not Applicable Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962369
Page 58 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962370
Page 59 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962371
Page 60 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962372
Page 61 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962373
Page 62 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962374
Page 63 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962375
Page 64 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962376
Page 65 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962377
Page 66 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962378
Page 67 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962379
Page 68 of 428
***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: 10841538 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.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962380
Page 69 of 428
***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
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962381
Page 70 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962382
Page 71 of 428
***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: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962383
Page 72 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962384
Page 73 of 428
***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
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962385
Page 74 of 428
***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: 10841538 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:
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962386
Page 75 of 428
***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: 10841538 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 [ ]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962387
Page 76 of 428
***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: 10841538 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:
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962388
Page 77 of 428
***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: 10841538 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 [ ]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962389
Page 78 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#CategoryAE Identifi
erAdverse Ev
entStart DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 Bipolar I Jan/31/2021 UNK:U
NK YES Repeating
Pages
2. Repeating
Pages
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962390
Page 79 of 428
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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)[Bipolar I]
4.Start Date Time: Jan/31/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Depression]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962391
Page 80 of 428
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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?NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021145100]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962392
Page 81 of 428
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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:
2.AE ID: [ ] Comments
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
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).
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with Study
Treatment:
11.Was a Concomitant Medication
given?
12.Was a Non-Drug Treatment given?
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962393
Page 82 of 428
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
13.What was the outcome of this
adverse event?:
14.Did the adverse event cause the
subject to be discontinued from the
study?
15.Serious Adverse Event Number:
For Pfizer Use Only[2021145100]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962394
Page 83 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962395
Page 84 of 428
***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: 10841538 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[ ]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962396
Page 85 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962397
Page 86 of 428
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962398
Page 87 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962399
Page 88 of 428
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962400
Page 89 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962401
Page 90 of 428
***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: 10841538 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?
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962402
Page 91 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962403
Page 92 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962404
Page 93 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962405
Page 94 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Unplanned Assessments
1.Assessments
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962406
Page 95 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962407
Page 96 of 428
***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: 10841538 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:
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962408
Page 97 of 428
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962409
Page 98 of 428
***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: 10841538 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?
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962410
Page 99 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962411
Page 100 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962412
Page 101 of 428
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962413
Page 102 of 428
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962414
Page 103 of 428
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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 [ ]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962415
Page 104 of 428
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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 [ ]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962416
Page 105 of 428
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Dec/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962417
Page 106 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962418
Page 107 of 428
***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, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962419
Page 108 of 428
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962420
Page 109 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/20/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962421
Page 110 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962422
Page 111 of 428
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962423
Page 112 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/30/2020
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962424
Page 113 of 428
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Casebook Signature Form
1.Casebook Signature
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962425
Page 114 of 428
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962426
Page 115 of 428
***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: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormDec-04-2020 12:23:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962427
Page 116 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormFeb-22-2021 15:59:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962428
Page 117 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Feb-22-2021 15:59:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962429
Page 118 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Feb-22-2021 15:59:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962430
Page 119 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Feb-22-2021 15:59:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962431
Page 120 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Feb-22-2021 15:59:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962432
Page 121 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Feb-22-2021 15:59:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962433
Page 122 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Feb-22-2021 15:59:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962434
Page 123 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
7Feb-22-2021 15:59:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962435
Page 124 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
8Feb-22-2021 15:59:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962436
Page 125 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
9Feb-22-2021 15:59:31 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962437
Page 126 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-12-2021 11:17:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962438
Page 127 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-12-2021 11:17:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962439
Page 128 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Mar-12-2021 11:17:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962440
Page 129 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Mar-12-2021 11:17:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962441
Page 130 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Mar-12-2021 11:17:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962442
Page 131 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Mar-12-2021 11:17:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962443
Page 132 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Mar-12-2021 11:17:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962444
Page 133 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-12-2021 11:14:56 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962445
Page 134 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-12-2021 11:14:56 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962446
Page 135 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Mar-12-2021 11:14:56 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962447
Page 136 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Mar-12-2021 11:14:56 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962448
Page 137 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Mar-12-2021 11:14:56 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962449
Page 138 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962450
Page 139 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962451
Page 140 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Mar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962452
Page 141 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Mar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962453
Page 142 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Mar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962454
Page 143 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962455
Page 144 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962456
Page 145 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962457
Page 146 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962458
Page 147 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962459
Page 148 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962460
Page 149 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962461
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962462
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962463
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962464
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962465
Page 154 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962466
Page 155 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962467
Page 156 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962468
Page 157 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962469
Page 158 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962470
Page 159 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962471
Page 160 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962472
Page 161 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962473
Page 162 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962474
Page 163 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 fMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962475
Page 164 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 fMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962476
Page 165 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 fMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962477
Page 166 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 fMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962478
Page 167 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962479
Page 168 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962480
Page 169 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0962481
Page 170 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gMar-12-2021 11:14:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962482
Page 171 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962483
Page 172 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962484
Page 173 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Mar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962485
Page 174 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Mar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962486
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Mar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962487
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962488
Page 177 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962489
Page 178 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962490
Page 179 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.aMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962491
Page 180 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962492
Page 181 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962493
Page 182 of 428
***Confidential***
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Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962494
Page 183 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.bMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962495
Page 184 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962496
Page 185 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962497
Page 186 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962498
Page 187 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.cMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962499
Page 188 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0962500
Page 189 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962501
Page 190 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962502
Page 191 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.dMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962503
Page 192 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962504
Page 193 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962505
Page 194 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962506
Page 195 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.eMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962507
Page 196 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 fMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962508
Page 197 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 fMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962509
Page 198 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 fMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962510
Page 199 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 fMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962511
Page 200 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962512
Page 201 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962513
Page 202 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962514
Page 203 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.gMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962515
Page 204 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 hMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962516
Page 205 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 hMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962517
Page 206 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 hMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962518
Page 207 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5 hMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962519
Page 208 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.iMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962520
Page 209 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.iMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962521
Page 210 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.iMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962522
Page 211 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.iMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962523
Page 212 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.jMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962524
Page 213 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.jMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962525
Page 214 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.jMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962526
Page 215 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5.jMar-12-2021 11:08:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962527
Page 216 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-12-2021 11:09:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962528
Page 217 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-12-2021 11:09:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962529
Page 218 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.aMar-12-2021 11:09:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962530
Page 219 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.aMar-12-2021 11:09:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962531
Page 220 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.aMar-12-2021 11:09:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962532
Page 221 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.aMar-12-2021 11:09:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962533
Page 222 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-12-2021 10:26:44 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962534
Page 223 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-12-2021 10:26:44 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962535
Page 224 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2.aMar-12-2021 10:26:44 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962536
Page 225 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-12-2021 10:26:07 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962537
Page 226 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-12-2021 10:26:07 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962538
Page 227 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Mar-12-2021 10:26:07 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962539
Page 228 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Mar-12-2021 10:26:07 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962540
Page 229 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-12-2021 10:25:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962541
Page 230 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-12-2021 10:25:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962542
Page 231 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Mar-12-2021 10:25:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962543
Page 232 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Mar-12-2021 10:25:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962544
Page 233 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Mar-12-2021 10:25:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962545
Page 234 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Mar-12-2021 10:25:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962546
Page 235 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Mar-12-2021 10:25:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962547
Page 236 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormMar-12-2021 10:23:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962548
Page 237 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Mar-12-2021 10:23:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962549
Page 238 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Mar-12-2021 10:23:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962550
Page 239 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Mar-12-2021 10:23:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962551
Page 240 of 428
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/06/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Mar-12-2021 10:23:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962552
Page 241 of 428
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Mar-12-2021 10:20:50 (UTC-06:00) Central
Time (US & Canada)
2Mar-12-2021 10:19:30 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962553
Page 242 of 428
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962554
Page 243 of 428
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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
Dec-03-2020 00:42:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 1: Closed Response satisfies
query
Dec-02-2020 11:35:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
06 OCT 2020Subject consented
under Amendment
8 version
15OCT2020 but
this is not an option
to choose from.
Dec-02-2020 11:27:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Subject consented
under Amendment
6
Dec-02-2020 11:27:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Subject consented
under Amendment
6
Dec-01-2020 00:58:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM : Thanks for
response. Please
confirm whether
this subject
consented under
protocol
amendment 4 dated
30Jun2020. If not,
please update the
correct protocol
version date. Thank
you.
Nov-30-2020 12:34:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Nov-25-2020 01:15:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 1: Opened Subject's age is 16
years at the time of
Informed consent
collection. Please
confirm whether
this subject
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0962555
Page 244 of 428
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
consented under
protocol
amendment 4 dated
30Jun2020. If not,
please update the
correct protocol
version date. Thank
you.
Nov-06-2020 11:56:08
(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
Nov-06-2020 11:56:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0962556
Page 245 of 428
***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, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Nov-06-2020 11:56:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Nov/6/2020Initial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962557
Page 246 of 428
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-06-2020 11:55:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10841538Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Nov-06-2020 11:55:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/2004Enrollment Entry
3. Sex:
Date Location User Value Reason
Nov-06-2020 11:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Nov-06-2020 11:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR O
F SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Nov-06-2020 11:56:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962558
Page 247 of 428
***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, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-07-2020 00:38:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-04-2020 12:22:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered updated
Dec-03-2020 05:27:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly review
and complete ‘HIV
and Inclusion and
Exclusion form' at
this visit. Thank
you.
Nov-06-2020 11:56:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/6/2020Initial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0962559
Page 248 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Male or female participants betwee
n the ages of 18 and 55 years, inclu
sive, 65 and 85 years, inclusive, or
18 and 85 years, inclusive, at rando
mization (dependent upon study staInitial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962560
Page 249 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
ge)
1.a Criterion met?
Date Location User Value Reason
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Nov-06-2020 11:56:49
(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 proced
ures
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN02A00Initial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962561
Page 250 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.b Inclusion Number:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participants who are willing and ab
le to comply with all scheduled visi
ts, vaccination plan, laboratory test
s, lifestyle considerations, and othe
r study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (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-2021-5683-0962562
Page 251 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Healthy participants who
are determined by medical
history, physical examinat
ion, and clinical judgment
of the investigator to be el
igible for inclusion in the
study
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN03A00
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962563
Page 252 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.c Inclusion Number:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Healthy participants who are deter
mined by medical history, physical
examination, and clinical judgment
of the investigator to be eligible for
inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (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-2021-5683-0962564
Page 253 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Capable of giving persona
l signed informed consent,
which includes complianc
e with the requirements an
d restrictions listed in the
ICD and in this protocol
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN04A00
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962565
Page 254 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.d Inclusion Number:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Capable of giving personal signed i
nformed consent, which includes c
ompliance with the requirements an
d restrictions listed in the ICD and i
n this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:1Initial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (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-2021-5683-0962566
Page 255 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Other medical or psychiatr
ic condition incl. recent (w
ithin past year) or active s
uicidal ideation/behavior/l
ab abnormality that may i
ncrease the risk of study p
articipation
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Other medical or psychiatric condit
ion incl. recent (within past year) o
r active suicidal ideation/behavior/l
ab abnormality that may increase th
e risk of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962567
Page 256 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with h
uman immunodeficiency
virus (HIV), hepatitis C
virus (HCV), or hepatiti
s B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use onl
y):EX02A00Initial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962568
Page 257 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.b Exclusion Number:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Nov-06-2020 11:56:49
(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 of
the study intervention(s)Initial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (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-2021-5683-0962569
Page 258 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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)
:EX03A00
2.c Exclusion Number:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
History of severe adverse reaction
associated with a vaccine and/or se
vere allergic reaction (eg, anaphyla
xis) to any component of the study
intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962570
Page 259 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Nov-06-2020 11:56:49
(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 u
se only):EX04A00Initial Entry
2.d Exclusion Number:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of medications intended to
prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (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-2021-5683-0962571
Page 260 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:8
Criteri
on Des
criptio
n:Immunocompromised ind
ividuals with known or su
spected immunodeficienc
y, as determined by histor
y and/or laboratory/physi
cal examination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX08A00Initial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962572
Page 261 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.e Exclusion Number:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Immunocompromised individuals
with known or suspected immunod
eficiency, as determined by history
and/or laboratory/physical examina
tionInitial Entry
2.e Criterion met?
Date Location User Value Reason
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:10Initial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (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-2021-5683-0962573
Page 262 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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 woul
d, in the opinion of the in
vestigator, contraindicate
intramuscular injection
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX10A00
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962574
Page 263 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.f Exclusion Number:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition ass
ociated with prolonged bleeding th
at would, in the opinion of the inve
stigator, contraindicate intramuscul
ar injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:11
Criterion Desc
ription:Women who are
pregnant or breast
feeding
Criterion met?
:NOInitial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (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-2021-5683-0962575
Page 264 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterion ID: (
For Pfizer use
only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinati
on with any corona
virus vaccineInitial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (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-2021-5683-0962576
Page 265 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Previous vaccination with any coro
navirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:13Initial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (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-2021-5683-0962577
Page 266 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 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?:NO
Criterio
n ID: (Fo
r Pfizer
use only)
:EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Subjects who receive immunosuppr
essive therapy, such as cytotoxic ag
ents or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
2.j
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962578
Page 267 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:15
Criteri
on Des
criptio
n:Receipt of blood/plasma p
roducts or immunoglobuli
n, from 60 days before stu
dy intervention administr
ation or planned receipt th
roughout the study
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX14A01Initial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962579
Page 268 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.j Exclusion Number:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma products o
r immunoglobulin, from 60 days be
fore study intervention administrati
on or planned receipt throughout th
e studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962580
Page 269 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
2.k
Date Location User Value Reason
Nov-06-2020 11:56:49
(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?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX15A01Initial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962581
Page 270 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.k Exclusion Number:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participation in other studies invol
ving study intervention within 28 d
ays prior to study entry and/or duri
ng study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Nov-06-2020 11:56:49
(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
clesInitial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (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-2021-5683-0962582
Page 271 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Previous participation in other stud
ies involving study intervention co
ntaining lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Nov-06-2020 11:56:49
(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
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Nov-06-2020 11:56:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus22Initial Entry
090177e196ae3f82\Final\Final On: 01-Apr-2021 05:17 (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-2021-5683-0962583
Page 272 of 428
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841538 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
ion Nu
mber:
Criter
ion De
scripti
on:Investigator site staff or Pf
izer employees direc
…[truncated]