Document text
Page 1 of 213
***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: 10181031 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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786886
Page 2 of 213
***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: 10181031 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/3/2020
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786887
Page 3 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10181031]
2.Birth Date: 984
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786888
Page 4 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/3/2020
2.Erroneous Visit
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786889
Page 5 of 213
***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: 10181031 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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786890
Page 6 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786891
Page 7 of 213
***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: 10181031 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:[Seasonal Allergies]
Start Date: UNK/UNK/1995
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hyperlipidemia]
Start Date: UNK/UNK/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Benign prostatic hyperplasia]
Start Date: UNK/UNK/2013
Ongoing: YES
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786892
Page 8 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Cholecystectomy]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Cholecystitis]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786893
Page 9 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/3/2020
2.Weight: [173.4]
3.Unit: LB
4.Height: [70.0]
5.Unit: in
6.Body Mass Index: [24.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786894
Page 10 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/3/2020
2.Randomization Number: [41766]
3.Randomization Group: [ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786895
Page 11 of 213
***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: 10181031 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/3/2020
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 [BHTXPV]
5.bSample ID [BHTXPX]
5.cSample ID [BHTXPW]
5.dSample ID [BPG5YS]
5.eSample ID [BPG5YR]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786896
Page 12 of 213
***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: 10181031 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/3/2020
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 [BHTXRS]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786897
Page 13 of 213
***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: 10181031 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/3/2020 13:05
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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786898
Page 14 of 213
***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: 10181031 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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786899
Page 15 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786900
Page 16 of 213
***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: 10181031 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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786901
Page 17 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786902
Page 18 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786903
Page 19 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786904
Page 20 of 213
***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: 10181031 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/24/2020
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 [BN5NGP]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786905
Page 21 of 213
***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: 10181031 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/24/2020 09:54
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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786906
Page 22 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786907
Page 23 of 213
***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: 10181031 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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786908
Page 24 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786909
Page 25 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786910
Page 26 of 213
***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: 10181031 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/25/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9FV3]
5.bSample ID [BP9FV4]
5.cSample ID [BLB1NC]
5.dSample ID [BLB1ND]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786911
Page 27 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786912
Page 28 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786913
Page 29 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 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 [ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786914
Page 30 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 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 [ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786915
Page 31 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786916
Page 32 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786917
Page 33 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786918
Page 34 of 213
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 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 [ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786919
Page 35 of 213
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786920
Page 36 of 213
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786921
Page 37 of 213
***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: 10181031 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/25/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786922
Page 38 of 213
***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: 10181031 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: [ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786923
Page 39 of 213
***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: 10181031 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:
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786924
Page 40 of 213
***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: 10181031 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 [ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786925
Page 41 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Iden
tifierAdverse
EventStart DateIs the Adverse Event S
till OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Appendici
tis Jan/6/2021
10:00 NO
End Date Time:
Jan/8/2021 14:00
Repeating
Pages
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786926
Page 42 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10181031 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)[Appendicitis]
4.Start Date Time: Jan/6/2021 10:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/8/2021 14:00
6.Toxicity Grade: 4
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786927
Page 43 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
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:
[appendicitis; cause unknown]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786928
Page 44 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021046060]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786929
Page 45 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786930
Page 46 of 213
***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: 10181031 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[ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786931
Page 47 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786932
Page 48 of 213
***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: 10181031 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: //
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786933
Page 49 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786934
Page 50 of 213
***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: 10181031 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?
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786935
Page 51 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786936
Page 52 of 213
***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: 10181031 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?
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786937
Page 53 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786938
Page 54 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786939
Page 55 of 213
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786940
Page 56 of 213
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10181031 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:
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786941
Page 57 of 213
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10181031 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?
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786942
Page 58 of 213
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786943
Page 59 of 213
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786944
Page 60 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/16/2021
2.Erroneous Visit
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786945
Page 61 of 213
***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: 10181031 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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786946
Page 62 of 213
***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: 10181031 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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786947
Page 63 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786948
Page 64 of 213
***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: 10181031 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: [ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786949
Page 65 of 213
***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: 10181031 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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786950
Page 66 of 213
***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: 10181031 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/19/2021
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786951
Page 67 of 213
***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: 10181031 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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786952
Page 68 of 213
***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: 10181031 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/19/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786953
Page 69 of 213
***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: 10181031 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/19/2021
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 [BR94RB]
5.bSample ID [BR94RC]
5.cSample ID [BPG6M8]
5.dSample ID [BPG6M9]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786954
Page 70 of 213
***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: 10181031 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/19/2021
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 [BR94WF]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786955
Page 71 of 213
***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: 10181031 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/19/2021 10:39
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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786956
Page 72 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786957
Page 73 of 213
***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: 10181031 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/9/2021
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 [BR1326]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786958
Page 74 of 213
***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: 10181031 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/9/2021 10:34
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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786959
Page 75 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786960
Page 76 of 213
***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: 10181031 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/10/2021
3.Comments: [ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786961
Page 77 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786962
Page 78 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786963
Page 79 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786964
Page 80 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786965
Page 81 of 213
***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: 10181031 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/10/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786966
Page 82 of 213
***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: 10181031 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/25/2020
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786967
Page 83 of 213
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10181031 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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786968
Page 84 of 213
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10181031 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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786969
Page 85 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-04-2020 17:07:06 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786970
Page 86 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-19-2021 13:34:50
(UTC-06:00) Central Time (US &
Canada)William
FernandezNot Applicable
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0786971
Page 87 of 213
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10181031 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-10-2021 13:13:35 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-25-2021 13:34:46 (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-25-2021 04:23:04 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786972
Page 88 of 213
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
N/A
Approved Jan-23-2021 15:52:36 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages
accurately display the results of the examinations, tests, evaluations and treatments performed on
this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
N/A Jan-22-2021 10:39:59 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 15:57:03 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786973
Page 89 of 213
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10181031 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 Jan-19-2021 13:32:07 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-12-2020 19:01:50 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786974
Page 90 of 213
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10181031 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-25-2020 14:20:03 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Sep-14-2020 13:53:00 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786975
Page 91 of 213
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: 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: 10181031 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.
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786976
Page 92 of 213
***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: 10181031 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-04-2020
08:25:06
(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-04-2020
08:25:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786977
Page 93 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-04-2020
08:25:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/3/2020Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786978
Page 94 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-04-2020
08:02:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10181031Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-04-2020
08:02:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1984Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-04-2020
08:25:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786979
Page 95 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020
08:25:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATI
NO(A) OR OF SPAN
ISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-04-2020
08:25:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786980
Page 96 of 213
***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: 10181031 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-04-2020
08:26:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/3/2020Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786981
Page 97 of 213
***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: 10181031 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-04-2020
08:26:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-04-2020
08:26:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-04-2020
08:26:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786982
Page 98 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-04-2020
08:27:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical Hi
story Term:Seasonal
Allergies
Start Date: UNK/U
NK/1995
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-04-2020
08:27:22
(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-04-2020
08:27:22
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Data Entry:
Seasonal AllergiesInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786983
Page 99 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-04-2020
08:27:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-04-2020
08:27:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-04-2020
08:27:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Hyperlip
idemia
Start Date: UNK/U
NK/201
9Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786984
Page 100 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: YES
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786985
Page 101 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-04-2020
08:27:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-04-2020
08:27:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HyperlipidemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-04-2020
08:27:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786986
Page 102 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020
08:27:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-04-2020
08:28:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical
History T
erm:Benign pro
static hyper
plasia
Start Dat
e:UNK/UNK
/2013
Ongoing: YESInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786987
Page 103 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-04-2020
08:28:38
(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-04-2020
08:28:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Benign prostatic hyp
erplasiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-04-2020
08:28:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786988
Page 104 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020
08:28:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-04-2020
08:29:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical H
istory Ter
m:Cholecyste
ctomy
Start Date
:UNK/UN
K/2016
Ongoing: NO
End Date
:
UNK/U
NK/201
6Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786989
Page 105 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-04-2020
08:29:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-04-2020
08:29:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CholecystectomyInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-04-2020
08:29:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.d Ongoing:
Date Location User Value Reason
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786990
Page 106 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020
08:29:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
1.e
Date Location User Value Reason
Aug-04-2020
08:29:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical H
istory Ter
m:Cholecysti
tis
Start Date
:UNK/UN
K/2016
Ongoing: NO
End Date
:
UNK/U
NK/201
6Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786991
Page 107 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-04-2020
08:29:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-04-2020
08:29:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
CholecystitisInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-04-2020
08:29:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.e Ongoing:
Date Location User Value Reason
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786992
Page 108 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020
08:29:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786993
Page 109 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-04-2020
08:30:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-04-2020
08:30:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
173.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-04-2020
08:30:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786994
Page 110 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-04-2020
08:30:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
70.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-04-2020
08:30:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-04-2020
08:30:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24.9Initial Entry
7.a
Date Location User Value Reason
Aug-04-2020
08:30:55
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
Record Ide 1Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786995
Page 111 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)ntifier::
Temperatu
re:97.4
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-04-2020
08:30:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-04-2020
08:30:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
97.4Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786996
Page 112 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020
08:30:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-04-2020
08:30:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786997
Page 113 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-04-2020
08:31:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-04-2020
08:31:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
41766Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786998
Page 114 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-04-2020
08:32:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-04-2020
08:32:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-04-2020
08:32:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-04-2020
08:32:03ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786999
Page 115 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-04-2020
08:32:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Aug/3/2020Initial Entry
5.a
Date Location User Value Reason
Aug-04-2020
08:32:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BHTXP
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-04-2020
08:32:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BHTXPVInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787000
Page 116 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b
Date Location User Value Reason
Aug-04-2020
08:32:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BHTXP
XInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-04-2020
08:32:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BHTXPXInitial Entry
5.c
Date Location User Value Reason
Aug-04-2020
08:32:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BHTXP
WInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787001
Page 117 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Aug-04-2020
08:32:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BHTXPWInitial Entry
5.d
Date Location User Value Reason
Aug-04-2020
08:32:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPG5Y
SInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-04-2020
08:32:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPG5YSInitial Entry
5.e
Date Location User Value Reason
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787002
Page 118 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020
08:32:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BPG5Y
RInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-04-2020
08:32:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPG5YRInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787003
Page 119 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-04-2020
16:13:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-04-2020
16:13:33
(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-04-2020
16:14:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-04-2020
16:13:33ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787004
Page 120 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-04-2020
16:13:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection
:
Aug/3/2020Initial Entry
5.a
Date Location User Value Reason
Aug-04-2020
16:14:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BHTXR
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-04-2020
16:14:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BHTXRSInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787005
Page 121 of 213
***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: 10181031 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-04-2020
09:02:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-04-2020
09:02:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-04-2020
09:02:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787006
Page 122 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020
09:02:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/3/2020 13:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-04-2020
09:02:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-04-2020
09:02:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-04-2020
09:02:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787007
Page 123 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-04-2020
09:02:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-04-2020
09:02:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787008
Page 124 of 213
***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: 10181031 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-04-2020
09:02:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGE
NICITY E-DIARY C
OLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787009
Page 125 of 213
***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: 10181031 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-24-2020
11:26:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787010
Page 126 of 213
***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: 10181031 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-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
2.a Symptom:
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787011
Page 127 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-24-2020
11:27:07
(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
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
EInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787012
Page 128 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:N
O
2.b Symptom:
Date Location User Value Reason
Aug-24-2020
11:27:07
(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
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-24-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787013
Page 129 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11:27:07
(UTC-06:00)
Central Time (US
& Canada)Symptom:: HE
A
D
AC
HE
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:N
O
2.c Symptom:
Date Location User Value Reason
Aug-24-2020
11:27:07
(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
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787014
Page 130 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.d
Date Location User Value Reason
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
L
L
S
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787015
Page 131 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.d Symptom:
Date Location User Value Reason
Aug-24-2020
11:27:07
(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
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NGInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787016
Page 132 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:NO
2.e Symptom:
Date Location User Value Reason
Aug-24-2020
11:27:07
(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
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-24-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787017
Page 133 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11:27:07
(UTC-06:00)
Central Time (US
& Canada)Symptom:: DI
A
RR
HE
A
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:N
O
2.f Symptom:
Date Location User Value Reason
Aug-24-2020
11:27:07
(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
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787018
Page 134 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.g
Date Location User Value Reason
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AIN
Were fever
or systemic
symptoms
present on t
he last day
the Subject
Diary was c
ompleted?:NOInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787019
Page 135 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.g Symptom:
Date Location User Value Reason
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSE
NED MUSCLE PAI
NInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR
WOR
SENE
D JOI
NT P
AINInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787020
Page 136 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was co
mpleted?:NO
2.h Symptom:
Date Location User Value Reason
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSE
NED 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
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787021
Page 137 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-24-2020
11:27:07
(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-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::RE
D
N
ES
S
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:N
OInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787022
Page 138 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-24-2020
11:27:07
(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
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::SW
EL
LI
NGInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787023
Page 139 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were injectio
n site reaction
s present on t
he last day the
Subject Diary
was complete
d?:NO
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-24-2020
11:27:07
(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
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-24-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787024
Page 140 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11:27:07
(UTC-06:00)
Central Time (US
& Canada)Injection Sit
e Reaction::PAI
N A
T IN
JEC
TIO
N SI
TE
Were injecti
on site reacti
ons present o
n the last da
y the Subject
Diary was co
mpleted?:NO
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787025
Page 141 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-24-2020
11:27:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787026
Page 142 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-24-2020
11:27:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2.a
Date Location User Value Reason
Aug-24-2020
11:27:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Id
entifier::1
Temperat
ure:97.7
Temperat
ure Unit:F
Temperat
ure Locati
on::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-24-2020
11:27:26
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787027
Page 143 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)
2.a Temperature:
Date Location User Value Reason
Aug-24-2020
11:27:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
97.7Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-24-2020
11:27:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Aug-24-2020
11:27:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787028
Page 144 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020
11:27:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020
11:27:38
(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-24-2020
11:27:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-24-2020
11:27:38ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787029
Page 145 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-24-2020
11:27:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-24-2020
11:27:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BN5NG
PInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-24-2020
11:27:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BN5NGPInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787030
Page 146 of 213
***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: 10181031 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-24-2020
11:28:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-24-2020
11:28:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-24-2020
11:28:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787031
Page 147 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-24-2020
11:28:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020 09:54Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-24-2020
11:28:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-24-2020
11:28:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-24-2020
11:28:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787032
Page 148 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-24-2020
11:28:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-24-2020
11:28:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787033
Page 149 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-25-2020
15:01:39
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Transcription
Error
Sep-25-2020
14:20:03
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/24/2020Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787034
Page 150 of 213
***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: 10181031 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-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:N
OInitial Entry
2.a Symptom:
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787035
Page 151 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-25-2020
14:21:04
(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-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
EInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787036
Page 152 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:N
O
2.b Symptom:
Date Location User Value Reason
Sep-25-2020
14:21:04
(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-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-25-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787037
Page 153 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14:21:04
(UTC-06:00)
Central Time (US
& Canada)Symptom:: HE
A
D
A
C
HE
Were fever or
systemic sym
ptoms present
on the last da
y the Subject
Diary was co
mpleted?:N
O
2.c Symptom:
Date Location User Value Reason
Sep-25-2020
14:21:04
(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-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787038
Page 154 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.d
Date Location User Value Reason
Sep-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
L
L
S
Were fever or
systemic symp
toms present o
n the last day t
he Subject Dia
ry was comple
ted?:N
OInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787039
Page 155 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.d Symptom:
Date Location User Value Reason
Sep-25-2020
14:21:04
(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-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NGInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787040
Page 156 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were fever or
systemic sym
ptoms present
on the last da
y the Subject
Diary was co
mpleted?:NO
2.e Symptom:
Date Location User Value Reason
Sep-25-2020
14:21:04
(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-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-25-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787041
Page 157 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14:21:04
(UTC-06:00)
Central Time (US
& Canada)Symptom:: DI
A
R
R
H
E
A
Were fever or
systemic symp
toms present
on the last da
y the Subject
Diary was co
mpleted?:N
O
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787042
Page 158 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.f Symptom:
Date Location User Value Reason
Sep-25-2020
14:21:04
(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-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR
WOR
SENE
D M
USCL
E PAI
NInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787043
Page 159 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were fever
or systemic
symptoms
present on
the last day
the Subject
Diary was
completed?
:NO
2.g Symptom:
Date Location User Value Reason
Sep-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSE
NED MUSCLE PA
INInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787044
Page 160 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR
WOR
SEN
ED J
OINT
PAIN
Were fever
or systemic
symptoms
present on t
he last day
the Subject
Diary was c
ompleted?:NOInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787045
Page 161 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h Symptom:
Date Location User Value Reason
Sep-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSE
NED 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-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-25-2020
14:21:04
(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
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787046
Page 162 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::R
E
D
N
ES
S
Were injectio
n site reaction
s present on t
he last day the
Subject Diary
was complete
d?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-25-2020
14:21:04
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787047
Page 163 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injectio
n site reaction
s present on t
he last day th
e Subject Dia
ry was compl
eted?:NOInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787048
Page 164 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-25-2020
14:21:04
(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-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Sit
e Reaction::PAI
N A
T IN
JEC
TIO
N SI
TEInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787049
Page 165 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were injecti
on site reacti
ons present
on the last d
ay the Subje
ct Diary was
completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTI
ON SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020
14:21:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787050
Page 166 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020
14:21:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020
14:21:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020
14:21:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-25-2020
14:21:22ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787051
Page 167 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-25-2020
14:21:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collectio
n:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020
14:21:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP9FV
3Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-25-2020
14:21:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9FV3Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787052
Page 168 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b
Date Location User Value Reason
Sep-25-2020
14:21:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP9FV
4Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-25-2020
14:21:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9FV4Initial Entry
5.c
Date Location User Value Reason
Sep-25-2020
14:22:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BLB1N
CInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787053
Page 169 of 213
***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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Sep-25-2020
14:22:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLB1NCInitial Entry
5.d
Date Location User Value Reason
Sep-25-2020
14:22:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BLB1N
DInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-25-2020
14:22:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLB1NDInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787054
Page 170 of 213
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 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
Sep-25-2020
14:22:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-25-2020
14:22:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-25-2020
14:22:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787055
Page 171 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Jan-21-2021
11:18:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787056
Page 172 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Jan-21-2021
11:18:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-21-2021
11:18:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-08-2021
16:33:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response
satisfies query
Mar-03-2021
16:38:02ACV0PFEINFP6000 Query 1: Answered 08JAN2021
subject was
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0787057
Page 173 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)discharged.
Mar-02-2021
06:53:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Medical
Monitor_ Pls
advise date of
discharge from
hospital for
this SAE.
Thanks
Jan-21-2021
11:18:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
AppendicitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-21-2021
11:18:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-21-2021
11:18:45
(UTC-06:00)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787058
Page 174 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada) Jan/8/2021 14:00
6. Toxicity Grade:
Date Location User Value Reason
Jan-21-2021
11:18:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Jan-26-2021
08:29:37
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Jan-26-2021
08:27:37
(UTC-06:00)
Central TimeACV0PFEINFP6000 Query 3: Closed Response
satisfies query
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787059
Page 175 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
Jan-25-2021
14:02:16
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Answere
dSAE form
reflecting this
information was
sent on
21Jan2021,
please see page
2
Jan-25-2021
10:42:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Answere
dInformation not
available
Jan-25-2021
04:23:04
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-22-2021
22:02:53
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Reissued
:OpenedClinical Thank
you. Serious
criterion for
SAE are 'Hosp'
and 'Life-
threatening';
however, SAE
report serious
criterion is
'Hosp'. Please
review,
harmonize
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787060
Page 176 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
reporting, and
update where
required (SAE
or AE)
Jan-22-2021
22:00:20
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Reissued
:OpenedClinical COVID
test status
(yes/no) during
Hosp was not
reported in the
SAE. Please
submit a
follow-up SAE
form
[#2021046060]
to document if
COVID testing
was performed
(YES/NO or
info not
available) and if
yes, the date and
results.
Jan-22-2021
10:39:59
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answere
dChanged
Information
Jan-22-2021
10:39:59
(UTC-06:00)
Central TimeACV0PFEINFP6000 auto query
(autoquery)Query 2: Answere
dChanged
Information
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787061
Page 177 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
Jan-22-2021
10:39:59
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious ev
ent associated w
ith congenital an
omaly or birth d
efect?
NO
Did this serious
event result in d
eath?
NO
Did this serious
event require or
prolong hospital
ization?
YES
Did this serious
event result in p
ersistent or signi
ficant disability/
incapacity?
NO
Is this serious evChanged
Information
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787062
Page 178 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
ent life threateni
ng?
YES
Other medically
important seriou
s event
NO
Jan-21-2021
21:36:20
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical Serious
criterion for
SAE is 'Life-
Threatening';
however, SAE
report serious
criterion is
Hospitalization.
Please review,
harmonize
reporting, and
update where
applicable
Jan-21-2021
21:34:58
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical COVID
test status
(yes/no) during
Hosp was not
reported in the
SAE. Please
submit a
follow-up SAE
form
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787063
Page 179 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
[#2021046060]
to document if
COVID testing
was performed
(YES/NO or
info not
available) and if
yes, the date and
results.
Jan-21-2021
11:18:45
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
eFor AE
Appendicitis:
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Jan-21-2021
11:18:45
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious ev
ent associated w
ith congenital an
omaly or birth d
efect?
NO
Did this serious
event result in d
eath?Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787064
Page 180 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
NO
Did this serious
event require or
prolong hospital
ization?
NO
Did this serious
event result in p
ersistent or signi
ficant disability/
incapacity?
NO
Is this serious ev
ent life threateni
ng?
YES
Other medically
important seriou
s 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.
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787065
Page 181 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Jan-21-2021
11:18:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-21-2021
11:18:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this e
vent is due to:
OTHER
If Other, specify:
appendicitis; cau
se unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-21-2021
11:18:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787066
Page 182 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-21-2021
11:18:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-21-2021
11:18:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-21-2021
11:18:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787067
Page 183 of 213
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-21-2021
11:18:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-25-2021
04:23:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2021046060Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787068
Page 184 of 213
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021
13:32:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Jan/16/2021Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787069
Page 185 of 213
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-19-2021
13:37:43
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-19-2021
13:32:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candid
ateThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Jan-19-2021
13:32:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Participant is wil
ling to return for
Vaccination 3
Participant is:
eligible per lo
cal/national re
commendatioInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787070
Page 186 of 213
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
ns and confir
med to have r
eceived only
placebo at Va
ccination 1/2
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787071
Page 187 of 213
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-19-2021
13:37:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Jan/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-19-2021
13:37:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 William
FernandezData Entry:
ASSESS ELIGIBI
LITY FOR ADDIT
IONAL VACCINA
TIONInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787072
Page 188 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-24-2021
22:30:53
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Close
dResponse
satisfies query
Jan-22-2021
15:38:36
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Answ
eredChanged data per
query
Jan-22-2021
06:30:39
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Opene
dDM: Kindly
review and
complete
‘Immunogenicity
and Nasal Swab
forms' at this
visit. Thank you.
Jan-19-2021
13:33:35
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Jan/19/2021Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787073
Page 189 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-19-2021
13:34:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 William
FernandezData Entry:
OBTAINED
Date Written Con
sent Obtained
Jan/19/2021Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787074
Page 190 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
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: 10181031 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
Jan-19-2021
13:35:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Jan/19/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-19-2021
13:35:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Jan-19-2021
13:35:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 William
FernandezData Entry:
COMPLETEDInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787075
Page 191 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-22-2021
15:37:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-22-2021
15:37:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-22-2021
15:37:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-22-2021
15:37:05ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787076
Page 192 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-22-2021
15:37:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/19/2021Initial Entry
5.a
Date Location User Value Reason
Jan-22-2021
15:37:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR94RBInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-22-2021
15:37:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR94RBInitial Entry
5.b
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787077
Page 193 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Jan-22-2021
15:37:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR94RCInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-22-2021
15:37:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR94RCInitial Entry
5.c
Date Location User Value Reason
Jan-22-2021
15:37:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPG6M
8Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787078
Page 194 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Jan-22-2021
15:37:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPG6M8Initial Entry
5.d
Date Location User Value Reason
Jan-22-2021
15:37:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPG6M
9Initial Entry
5.d Sample ID
Date Location User Value Reason
Jan-22-2021
15:37:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPG6M9Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787079
Page 195 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-22-2021
15:38:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-22-2021
15:38:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-22-2021
15:38:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-22-2021
15:38:15ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787080
Page 196 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-22-2021
15:38:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/19/2021Initial Entry
5.a
Date Location User Value Reason
Jan-22-2021
15:38:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BR94W
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-22-2021
15:38:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR94WFInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787081
Page 197 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
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: 10181031 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
Jan-19-2021
13:37:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 William
FernandezData Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-19-2021
13:37:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-19-2021
13:37:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787082
Page 198 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-19-2021
13:37:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Jan/19/2021 10:39Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-19-2021
13:37:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-19-2021
13:37:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 William
FernandezData Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-19-2021
13:37:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787083
Page 199 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8. Actual Dose:
Date Location User Value Reason
Jan-19-2021
13:37:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-19-2021
13:37:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-19-2021
13:37:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787084
Page 200 of 213
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-19-2021
13:37:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 William
FernandezData Entry:
YESInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787085
Page 201 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-10-2021
13:13:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/9/2021Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787086
Page 202 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-10-2021
13:14:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-10-2021
13:14:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-10-2021
13:14:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-10-2021
13:14:11ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787087
Page 203 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - 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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-10-2021
13:14:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/9/2021Initial Entry
5.a
Date Location User Value Reason
Feb-10-2021
13:14:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR1326Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-10-2021
13:14:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BR1326Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787088
Page 204 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
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: 10181031 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
Feb-10-2021
13:14:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-10-2021
13:14:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-10-2021
13:14:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787089
Page 205 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-10-2021
13:14:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/9/2021 10:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-10-2021
13:14:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-10-2021
13:14:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-10-2021
13:14:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787090
Page 206 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8. Actual Dose:
Date Location User Value Reason
Feb-10-2021
13:14:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-10-2021
13:14:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-10-2021
13:14:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787091
Page 207 of 213
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-10-2021
13:14:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787092
Page 208 of 213
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-10-2021
16:41:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Mar/10/2021Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787093
Page 209 of 213
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail
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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-10-2021
16:41:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-10-2021
16:41:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 William
FernandezData Entry:
YES
Date of Contact:
Mar/10/2021Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787094
Page 210 of 213
***Confidential***
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit
Trail History
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: 10181031 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
Mar-10-2021
16:41:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Mar/10/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-10-2021
16:41:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
OPEN LABEL TREAT
MENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-10-2021
16:41:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 William
FernandezData Entry:
COMPLETEDInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787095
Page 211 of 213
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Sep-25-2020
14:22:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-04-2020
08:31:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-04-2020
08:26:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-22-2021
10:43:53
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Cl
osedResponse satisfies query
Jan-21-2021 ACV0PFEINFP6000 Query 1: An Changed data per query
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787096
Page 212 of 213
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development,
Inc.
Subject No: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11:23:16
(UTC-06:00)
Central Time
(US & Canada)swered
Jan-21-2021
04:58:19
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Query 1: Op
enedSAE
RECON:AER#2021046060
appendicitis (onset
date:06Jan2021)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Sep-25-2020
14:22:20
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry
:
Sep/25/2020Initial Entry
Aug-04-2020
08:31:30
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry
:
Aug/3/2020Initial Entry
Aug-04-2020
08:26:41
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry
:
Aug/3/2020Initial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787097
Page 213 of 213
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail 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: 10181031 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-10-2020
15:38:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae4019\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787098