125742 S1 M5 CRF c4591001 1018 10181090

Document text

Page 1 of 315
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment
5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787099
Page 2 of 315
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/6/2020
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787100
Page 3 of 315
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10181090]
2.Birth Date: 1989
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787101
Page 4 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/6/2020
2.Erroneous Visit
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787102
Page 5 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787103
Page 6 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/6/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787104
Page 7 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hair Loss]
Start Date: UNK/UNK/2014
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[broken right lower jaw]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[right lower jaw surgery]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787105
Page 8 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/6/2020
2.Weight: [177.0]
3.Unit: LB
4.Height: [71.0]
5.Unit: in
6.Body Mass Index: [24.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [96.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787106
Page 9 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/6/2020
2.Randomization Number: [43680]
3.Randomization Group: [ ]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787107
Page 10 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/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 [BHTXV6]
5.bSample ID [BHTXV7]
5.cSample ID [BHTXV8]
5.dSample ID [BPG6FV]
5.eSample ID [BPG6FW]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787108
Page 11 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/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 [BHTXTY]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787109
Page 12 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/6/2020 12:29
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787110
Page 13 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787111
Page 14 of 315
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787112
Page 15 of 315
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787113
Page 16 of 315
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2 fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
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
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787114
Page 17 of 315
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [96.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787115
Page 18 of 315
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
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 [BN5NKY]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787116
Page 19 of 315
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/27/2020 09:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787117
Page 20 of 315
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787118
Page 21 of 315
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787119
Page 22 of 315
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2 fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
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
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787120
Page 23 of 315
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/28/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHTY3Y]
5.bSample ID [BHTY3Z]
5.cSample ID [BPG6JT]
5.dSample ID [BPG6JV]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787121
Page 24 of 315
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/13/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787122
Page 25 of 315
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/13/2020
2.Date of First Symptom Started: Nov/7/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/12/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
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? NO
4 hSymptoms: DIARRHEA
Was symptom present? YES
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787123
Page 26 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Headache]
5.bSymptoms - Other Text: [Nausea]
5.cSymptoms - Other Text: [Fatigue]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
 1.Nov/9/20
20 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
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(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/9/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT Unknown]
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FDA-CBER-2021-5683-0787126
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Nov/13/2020
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 [CV28968]
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(b) (4)
FDA-CBER-2021-5683-0787127
Page 30 of 315
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[Subject did home swab instead]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
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(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
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(b) (4)
FDA-CBER-2021-5683-0787129
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
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(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatme
ntTreatme
ntStart Da
teForm Instance
 1.Not Done  Not Done  Not Done
 Not Done
 Not Done
 Repeating
Pages
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787131
Page 34 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787132
Page 35 of 315
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: 3
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(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787134
Page 37 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787135
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done
 Not Done  Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one Repeating
Pages
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787136
Page 39 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787137
Page 40 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
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(b) (4)
FDA-CBER-2021-5683-0787138
Page 41 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787139
Page 42 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
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(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0787141
Page 44 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787142
Page 45 of 315
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0787143
Page 46 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
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(b) (4)
FDA-CBER-2021-5683-0787144
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787145
Page 48 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
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(b) (4)
FDA-CBER-2021-5683-0787146
Page 49 of 315
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxygen
)Form Instance
 1.      Repeating Pages
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787147
Page 50 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787148
Page 51 of 315
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787149
Page 52 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787150
Page 53 of 315
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787151
Page 54 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787152
Page 55 of 315
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/11/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/11/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787153
Page 56 of 315
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/11/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/11/2020
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 [BPVWH3]
5.bSample ID [BPVWH4]
5.cSample ID [BMNKC7]
5.dSample ID [BMNKC8]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787154
Page 57 of 315
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787155
Page 58 of 315
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787156
Page 59 of 315
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Sep/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787157
Page 60 of 315
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787158
Page 61 of 315
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787159
Page 62 of 315
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787160
Page 63 of 315
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Deep Vein Thrombosis, left leg  Nov/27/2020
UNK:UNK YES  Repeating
Pages
 2.ADVERSE
EVENT 2  Pulmonary Embolism, bilateral, s
egmental and sub segmental Dec/14/2020
UNK:UNK YES  Repeating
Pages
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787161
Page 64 of 315
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Deep Vein Thrombosis, left leg]
4.Start Date Time: Nov/27/2020 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
YES
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787162
Page 65 of 315
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[Trauma, sports related]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?: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[2020503990]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787163
Page 66 of 315
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pulmonary Embolism, bilateral, segmental and sub segmental]
4.Start Date Time: Dec/14/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
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?
YES
Other medically important serious event
NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787164
Page 67 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[DVT of left leg, FH, marker]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020503990]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787165
Page 68 of 315
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787166
Page 69 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787167
Page 70 of 315
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787168
Page 71 of 315
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787169
Page 72 of 315
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787170
Page 73 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787171
Page 74 of 315
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787172
Page 75 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787173
Page 76 of 315
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787174
Page 77 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787175
Page 78 of 315
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787176
Page 79 of 315
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787177
Page 80 of 315
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787178
Page 81 of 315
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787179
Page 82 of 315
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787180
Page 83 of 315
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787181
Page 84 of 315
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 per local/national recommendations and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787182
Page 85 of 315
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787183
Page 86 of 315
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787184
Page 87 of 315
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787185
Page 88 of 315
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787186
Page 89 of 315
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/20/2021
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787187
Page 90 of 315
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787188
Page 91 of 315
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/20/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787189
Page 92 of 315
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/20/2021
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 [BR94SD]
5.bSample ID [BR94SF]
5.cSample ID [BMNJS2]
5.dSample ID [BMNJS3]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787190
Page 93 of 315
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/20/2021
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 [BR94S9]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787191
Page 94 of 315
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/20/2021 14:47
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787192
Page 95 of 315
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787193
Page 96 of 315
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/10/2021
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 [BR132R]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787194
Page 97 of 315
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/10/2021 16:01
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787195
Page 98 of 315
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787196
Page 99 of 315
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/11/2021
3.Comments: [ ]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787197
Page 100 of 315
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787198
Page 101 of 315
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787199
Page 102 of 315
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787200
Page 103 of 315
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787201
Page 104 of 315
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/11/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787202
Page 105 of 315
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/28/2020
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787203
Page 106 of 315
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787204
Page 107 of 315
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787205
Page 108 of 315
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-06-2020 13:04:23 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787206
Page 109 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-18-2020 10:12:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787207
Page 110 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-18-2020 10:12:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787208
Page 111 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-18-2020 10:12:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787209
Page 112 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-18-2020 10:12:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787210
Page 113 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-18-2020 10:12:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787211
Page 114 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Nov-18-2020 10:12:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787212
Page 115 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Nov-18-2020 10:12:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787213
Page 116 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-18-2020 10:12:10 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787214
Page 117 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-18-2020 10:12:10 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787215
Page 118 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-18-2020 10:12:10 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787216
Page 119 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-18-2020 10:12:10 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787217
Page 120 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-18-2020 10:12:10 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787218
Page 121 of 315
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787219
Page 122 of 315
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787220
Page 123 of 315
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787221
Page 124 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787222
Page 125 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787223
Page 126 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787224
Page 127 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787225
Page 128 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787226
Page 129 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787227
Page 130 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787228
Page 131 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787229
Page 132 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787230
Page 133 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787231
Page 134 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787232
Page 135 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787233
Page 136 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787234
Page 137 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787235
Page 138 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787236
Page 139 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787237
Page 140 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787238
Page 141 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787239
Page 142 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787240
Page 143 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787241
Page 144 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787242
Page 145 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787243
Page 146 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787244
Page 147 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787245
Page 148 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787246
Page 149 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787247
Page 150 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787248
Page 151 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787249
Page 152 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787250
Page 153 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gNov-18-2020 10:11:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787251
Page 154 of 315
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-20-2021 17:17:56 (UTC-06:00) Central
Time (US & Canada)William
FernandezNot Applicable
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787252
Page 155 of 315
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-02-2021 16:17:36 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-25-2021 15:33:45 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-04-2021 16:40:00 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Dec-15-2020 16:59:37 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787253
Page 156 of 315
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-11-2020 17:07:48 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Dec-07-2020 15:12:22 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-07-2020 10:35:43 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Dec-04-2020 13:37:19 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787254
Page 157 of 315
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
William
Fernandez N/A Nov-23-2020 08:27:41 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-18-2020 10:28:49 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-18-2020 10:03:19 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-16-2020 17:05:31 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787255
Page 158 of 315
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-16-2020 17:02:43 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-16-2020 17:02:22 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-16-2020 17:00:43 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-12-2020 19:29:00 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787256
Page 159 of 315
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Sep-28-2020 11:47:53 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Sep-14-2020 14:51:49 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787257
Page 160 of 315
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-06-2020 13:03:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-06-2020 13:03:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787258
Page 161 of 315
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-06-2020 13:03:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/6/2020Initial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787259
Page 162 of 315
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-06-2020 13:02:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10181090Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-06-2020 13:02:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1989Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-06-2020 13:04:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-06-2020 13:04:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-06-2020 13:04:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787260
Page 163 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-06-2020 13:04:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/6/2020Initial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787261
Page 164 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-06-2020 13:04:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-06-2020 13:04:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-06-2020 13:04:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787262
Page 165 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-06-2020 13:05:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Hair Loss
Start Date: UNK/UNK/
2014
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-06-2020 13:05:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-06-2020 13:05:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Hair LossInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-06-2020 13:05:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787263
Page 166 of 315
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-06-2020 13:05:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-06-2020 13:06:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histo
ry Term:broken right lo
wer jaw
Start Date: UNK/UNK/20
08
Ongoing: NO
End Date:
UNK/UNK/
2008Initial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787264
Page 167 of 315
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-06-2020 13:06:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-06-2020 13:06:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
broken right lower jawInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-06-2020 13:06:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-06-2020 13:06:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2008Initial Entry
1.c
Date Location User Value Reason
Aug-06-2020 13:07:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:right lower jaw
surgery
Start Date: UNK/UNK/200
8Initial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787265
Page 168 of 315
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/
2008
1.c Line/MH Number:
Date Location User Value Reason
Aug-06-2020 13:07:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-06-2020 13:07:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
right lower jaw surgeryInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-06-2020 13:07:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-06-2020 13:07:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2008Initial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787266
Page 169 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-06-2020 13:08:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/6/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-06-2020 13:08:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
177.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-06-2020 13:08:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-06-2020 13:08:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
71.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-06-2020 13:08:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (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-2021-5683-0787267
Page 170 of 315
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-06-2020 13:08:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24.7Initial Entry
7.a
Date Location User Value Reason
Aug-06-2020 13:08:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 96.9
Temperature Uni
t:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-06-2020 13:08:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-07-2020 06:58:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-06-2020 13:10:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Aug-06-2020 13:08:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature 96.9
F is outside of
Normal Range 97
- 99.5 F.
Aug-06-2020 13:08:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
96.9Initial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (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-2021-5683-0787268
Page 171 of 315
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a Unit:
Date Location User Value Reason
Aug-06-2020 13:08:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-06-2020 13:08:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787269
Page 172 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-06-2020 13:09:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/6/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-06-2020 13:09:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
43680Initial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787270
Page 173 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-06-2020 13:47:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-06-2020 13:47:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-06-2020 13:47:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-06-2020 13:47:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-06-2020 13:47:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/6/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787271
Page 174 of 315
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-06-2020 13:47:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHTXV6Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-06-2020 13:47:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BHTXV6Initial Entry
5.b
Date Location User Value Reason
Aug-06-2020 13:48:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHTXV7Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-06-2020 13:48:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BHTXV7Initial Entry
5.c
Date Location User Value Reason
Aug-06-2020 13:48:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHTXV8Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-06-2020 13:48:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BHTXV8Initial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787272
Page 175 of 315
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d
Date Location User Value Reason
Aug-06-2020 13:48:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPG6FVInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-06-2020 13:48:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPG6FVInitial Entry
5.e
Date Location User Value Reason
Aug-06-2020 13:48:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPG6FWInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-06-2020 13:48:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPG6FWInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787273
Page 176 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-06-2020 13:48:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-06-2020 13:48:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-06-2020 13:49:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-06-2020 13:48:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-06-2020 13:48:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/6/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787274
Page 177 of 315
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-06-2020 13:49:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHTXTYInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-06-2020 13:49:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BHTXTYInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787275
Page 178 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-06-2020 13:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-06-2020 13:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-06-2020 13:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-06-2020 13:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/6/2020 12:29Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-06-2020 13:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787276
Page 179 of 315
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-06-2020 13:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-06-2020 13:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-06-2020 13:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-06-2020 13:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787277
Page 180 of 315
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-06-2020 13:10:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-
DIARY COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787278
Page 181 of 315
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-27-2020 15:29:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Aug/27/2020Initial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787279
Page 182 of 315
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Symptom:: FE
V
ER
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
2.b
Date Location User Value Reason
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787280
Page 183 of 315
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Symptom:: FA
TI
GU
E
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Symptom:: HE
AD
AC
HE
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787281
Page 184 of 315
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.c Symptom:
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Symptom:: C
HI
LL
S
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:N
OInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787282
Page 185 of 315
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.d Symptom:
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Symptom:: VO
MI
TIN
G
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787283
Page 186 of 315
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.e Symptom:
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Symptom:: DI
AR
RH
EA
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787284
Page 187 of 315
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.f Symptom:
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787285
Page 188 of 315
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.g Symptom:
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NEW OR WORSENED MU
SCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Symptom:: NEW O
R WOR
SENED
JOINT
PAIN
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787286
Page 189 of 315
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h Symptom:
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NEW OR WORSENED JOI
NT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Injection Site Reactio
n::RE
DN
ES
SInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787287
Page 190 of 315
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Injection Site Reacti
on::SW
ELL
ING
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787288
Page 191 of 315
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Injection Site Reac
tion::PAIN
AT IN
JECTI
ON SI
TE
Were injection site
reactions present o
n the last day the S
ubject Diary was c
ompleted?:NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787289
Page 192 of 315
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 15:29:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787290
Page 193 of 315
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-27-2020 15:29:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Aug/27/2020Initial Entry
2.a
Date Location User Value Reason
Aug-27-2020 15:29:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Record Identifi
er::1
Temperature: 96.9
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-27-2020 15:29:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-28-2020
01:29:31 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Closed by DM:
AT.
Aug-27-2020
15:31:04 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  William
FernandezQuery 1: Answered per source
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787291
Page 194 of 315
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-27-2020
15:29:54 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature 96.9
F is outside of
Normal Range 97
- 99.5 F.
Aug-27-2020
15:29:54 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  William
FernandezData Entry:
96.9Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-27-2020 15:29:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Aug-27-2020 15:29:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
ORAL CAVITYInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787292
Page 195 of 315
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 15:30:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 15:30:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-27-2020
15:30:20 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020
15:30:14 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-27-2020
15:30:14 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  William
FernandezData Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787293
Page 196 of 315
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-27-2020 15:30:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Sample ID: BN5NKYInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 15:30:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
BN5NKYInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787294
Page 197 of 315
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-27-2020 15:30:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-27-2020 15:30:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-27-2020 15:30:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-27-2020 15:30:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Aug/27/2020 09:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-27-2020 15:30:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787295
Page 198 of 315
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-27-2020 15:30:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-27-2020 15:30:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-27-2020 15:30:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-27-2020 15:30:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
YESInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787296
Page 199 of 315
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-16-2020 18:32:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-16-2020 17:04:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Updated
Nov-16-2020 10:23:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Illness eDiary: As
per Illness ediary
records, subject
reported "Yes" for
the question "Have
you experienced
any of the
following?” for the
COVID-19
symptoms or
diagnosis on
12NOV2020. But
there is no COVID
Illness visit
reported in the
database.
Sep-28-2020 11:47:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020Initial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787297
Page 200 of 315
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787298
Page 201 of 315
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic
symptoms present on th
e last day the Subject Di
ary was completed?:NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787299
Page 202 of 315
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.c Symptom:
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (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-2021-5683-0787300
Page 203 of 315
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.e
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic
symptoms present on th
e last day the Subject Di
ary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787301
Page 204 of 315
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.f Symptom:
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787302
Page 205 of 315
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.g Symptom:
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSC
LE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787303
Page 206 of 315
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h Symptom:
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT
PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ES
SInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787304
Page 207 of 315
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:
:SW
ELL
ING
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787305
Page 208 of 315
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reacti
on::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787306
Page 209 of 315
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 11:53:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787307
Page 210 of 315
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020 11:55:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020 11:55:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020 11:55:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-28-2020 11:55:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-28-2020 11:55:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/28/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787308
Page 211 of 315
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-28-2020 11:55:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHTY3YInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-30-2020 00:17:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-29-2020 08:58:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Query is
ambiguous
Sep-29-2020 08:35:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened The Barcode
BHTY3Y is
recorded for two
subjects 10181090
and 10181190,
Please review and
update as
appropriate.
Sep-28-2020 11:55:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BHTY3YInitial Entry
5.b
Date Location User Value Reason
Sep-28-2020 11:56:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHTY3ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-28-2020 11:56:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BHTY3ZInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787309
Page 212 of 315
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c
Date Location User Value Reason
Sep-28-2020 11:56:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPG6JTInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-28-2020 11:56:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPG6JTInitial Entry
5.d
Date Location User Value Reason
Sep-28-2020 11:56:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPG6JVInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-28-2020 11:56:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPG6JVInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787310
Page 213 of 315
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-18-2020 11:28:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Nov-18-2020 10:09:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered updated
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Answer Auto
Query
Nov-18-2020 08:07:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Candidat
eSite is going to
update the SOD
form. Please
review and close
the query once
data has been
entered.
Nov-18-2020 03:22:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened DM: Kindly
review and
complete
‘Microbiology
Specimen Illness
Details form' at
this visit. Thank
you.
Nov-17-2020 20:00:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Will update ASAP
Nov-17-2020 08:34:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Date of Visit is
completed but
Date of
Assessment in the
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787311
Page 214 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Nov-16-2020 17:02:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-16-2020 17:00:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Nov-16-2020 17:00:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of Collection
in both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Nov-16-2020 17:00:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/13/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-16-2020 17:00:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787312
Page 215 of 315
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/13/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/7/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Dec-07-2020 11:21:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-07-2020 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Dec-07-2020 08:04:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SD states patient
reported other
symptoms as well.
Please add those
symptoms at the
bottom of the page
"Other". Thank
you.
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resol
ved:Initial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787313
Page 216 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov/12/2020
4.a
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCRE
ASED COUGH
Symptom
Present:NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787314
Page 217 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.b Symptoms:
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUG
HInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREAS
ED SHORTNESS O
F BREATH
Sympto
m Prese
nt:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHOR
TNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (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-2021-5683-0787315
Page 218 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.d
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED MUSCLE PAI
N
Sympto
m Presen
t:YESInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787316
Page 219 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.e Symptoms:
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSC
LE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR S
MELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (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-2021-5683-0787317
Page 220 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED SORE THRO
AT
Sympto
m Presen
t:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE
THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Presen
t:YESInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787318
Page 221 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.h Symptoms:
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.i
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITIN
G
Symptom Presen
t:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-18-2020 10:03:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (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-2021-5683-0787319
Page 222 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Dec-07-2020 10:35:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other: HeadacheInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Dec-07-2020 10:35:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HeadacheInitial Entry
5.b
Date Location User Value Reason
Dec-07-2020 10:36:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other: NauseaInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Dec-07-2020 10:36:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NauseaInitial Entry
5.c
Date Location User Value Reason
Dec-07-2020 10:36:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other: FatigueInitial Entry
5.c Symptoms - Other Text:
Date Location User Value Reason
Dec-07-2020 10:36:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FatigueInitial Entry
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787320
Page 223 of 315
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-18-2020 10:14:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787321
Page 224 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-18-2020 10:14:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/9/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-18-2020 10:14:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-18-2020 10:14:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-18-2020 10:14:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Nov-18-2020 10:14:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC T
ESTInitial Entry
6. Trade Name:
Date Location User Value Reason
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787322
Page 225 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/13/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-18-2020 10:14:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Nov-18-2020 10:14:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User ValueReason
Nov-24-2020
00:29:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse
satisfies query
Nov-23-2020
08:27:41
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dNew
Information
Nov-23-2020
08:27:41
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  William Fernandez Data
Entry
:
NALT
Unkn
ownNew
Information
Nov-23-2020
00:24:00
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Open
edDM2: Thank
you for
response. Per
CCG section
8.31.7, If the
Trade Name is
not known,
090177e196ae4012\Final\Final On: 01-Apr-2021 05:29 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787323
Page 226 of 315
***Confidential***
Header Text: c4591001
Visit: POT_
…[truncated]