Document text
Page 1 of 156
***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: 10181111 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
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787414
Page 2 of 156
***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: 10181111 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/10/2020
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787415
Page 3 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10181111]
2.Birth Date: 1983
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787416
Page 4 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/10/2020
2.Erroneous Visit
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787417
Page 5 of 156
***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: 10181111 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
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787418
Page 6 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787419
Page 7 of 156
***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: 10181111 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:[Penicillin allergy]
Start Date: UNK/UNK/1984
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Generalized Anxiety]
Start Date: Apr/UNK/2019
Ongoing: YES
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787420
Page 8 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/10/2020
2.Weight: [189.4]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [32.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787421
Page 9 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/10/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787422
Page 10 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/10/2020
2.Randomization Number: [45557]
3.Randomization Group: [ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787423
Page 11 of 156
***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: 10181111 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/10/2020
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 [BP6P9F]
5.bSample ID [BP6P9G]
5.cSample ID [BP6P9H]
5.dSample ID [BPG6H0]
5.eSample ID [BPG6H1]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787424
Page 12 of 156
***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: 10181111 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/10/2020
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 [BP6P9P]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787425
Page 13 of 156
***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: 10181111 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/10/2020 12:22
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787426
Page 14 of 156
***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: 10181111 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
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787427
Page 15 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787428
Page 16 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787429
Page 17 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787430
Page 18 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [96.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787431
Page 19 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/1/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787432
Page 20 of 156
***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: 10181111 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:
Sep/1/2020
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 [BN5NP6]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787433
Page 21 of 156
***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: 10181111 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: Sep/1/2020 13:19
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787434
Page 22 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787435
Page 23 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787436
Page 24 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787437
Page 25 of 156
***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: 10181111 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:
Oct/6/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9FVF]
5.bSample ID [BP9FVG]
5.cSample ID [BLB3N7]
5.dSample ID [BLB3N8]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787438
Page 26 of 156
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787439
Page 27 of 156
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 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 [ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787440
Page 28 of 156
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787441
Page 29 of 156
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 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 [ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787442
Page 30 of 156
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787443
Page 31 of 156
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 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 [ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787444
Page 32 of 156
***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: 10181111 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:
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787445
Page 33 of 156
***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: 10181111 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: [ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787446
Page 34 of 156
***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: 10181111 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 [ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787447
Page 35 of 156
***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: 10181111 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 [ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787448
Page 36 of 156
***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: 10181111 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?
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787449
Page 37 of 156
***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: 10181111 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:
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787450
Page 38 of 156
***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: 10181111 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:
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787451
Page 39 of 156
***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: 10181111 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 [ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787452
Page 40 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787453
Page 41 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787454
Page 42 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Oct/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787455
Page 43 of 156
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death :Not Applicable
//Comments
2.Phase of Disposition: Not Applicable Comments
3.Status: Not Applicable Comments
4.Specify Status: Not Applicable
[ ]Comments
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787456
Page 44 of 156
***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: 10181111 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:
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787457
Page 45 of 156
***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: 10181111 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 [ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787458
Page 46 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Exposure during Pre
gnancy Nov/24/2020 UNK
:UNK YES Repeating
Pages
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787459
Page 47 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 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)[Exposure during Pregnancy]
4.Start Date Time: Nov/24/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unprotected sexual activity]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787460
Page 48 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787461
Page 49 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787462
Page 50 of 156
***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: 10181111 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[ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787463
Page 51 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1.[ ] [ ] Repeating
Pages
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787464
Page 52 of 156
***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: 10181111 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: //
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787465
Page 53 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787466
Page 54 of 156
***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: 10181111 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?
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787467
Page 55 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787468
Page 56 of 156
***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: 10181111 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?
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787469
Page 57 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787470
Page 58 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787471
Page 59 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787472
Page 60 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 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:
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787473
Page 61 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787474
Page 62 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 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?
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787475
Page 63 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787476
Page 64 of 156
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787477
Page 65 of 156
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787478
Page 66 of 156
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787479
Page 67 of 156
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 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 [ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787480
Page 68 of 156
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 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 [ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787481
Page 69 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787482
Page 70 of 156
***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: 10181111 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 NOT willing to return for Vaccination 3 OR otherwise not eligible
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787483
Page 71 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/6/2021
2.Primary Reason for Unblinding: OTHER
If other, specify:
[Patient tested positive for pregnancy.]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787484
Page 72 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787485
Page 73 of 156
***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: 10181111 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: [ ]
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787486
Page 74 of 156
***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: 10181111 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 Oct/6/2020
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787487
Page 75 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 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
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787488
Page 76 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 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
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787489
Page 77 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-10-2020 13:14:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787490
Page 78 of 156
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormMar-12-2021 17:01:48 (UTC-06:00) Central
Time (US & Canada)The subject is still active in study.
FormMar-12-2021 17:00:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787491
Page 79 of 156
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Mar-12-2021 17:00:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787492
Page 80 of 156
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Mar-12-2021 17:00:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787493
Page 81 of 156
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Mar-12-2021 17:00:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787494
Page 82 of 156
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Mar-12-2021 17:00:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787495
Page 83 of 156
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Jan-20-2021 15:17:29 (UTC-06:00) Central Time
(US & Canada)As per CRF CG 8.50.2.5
Not Applicable
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787496
Page 84 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 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-22-2021 09:40:49 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-25-2021 20:34:10 (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-16-2021 13:46:07 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-12-2020 19:39:19 (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.
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787497
Page 85 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
William
Fernandez N/A Oct-06-2020 15:55:14 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Sep-14-2020 15:03:21 (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.
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787498
Page 86 of 156
***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: 10181111 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-10-2020 13:13:56
(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-10-2020 13:13:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787499
Page 87 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-10-2020 13:14:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/10/2020Initial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787500
Page 88 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-10-2020 13:13:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10181111Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-10-2020 13:13:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1983Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-10-2020 13:14:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-10-2020 13:14:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-10-2020 13:14:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787501
Page 89 of 156
***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: 10181111 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-10-2020 13:14:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020Initial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787502
Page 90 of 156
***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: 10181111 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-10-2020 13:14:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-10-2020 13:14:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-10-2020 13:14:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787503
Page 91 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-10-2020 13:15:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:Penicillin alle
rgy
Start Date: UNK/UNK/1
984
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-10-2020 13:15:11
(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-10-2020 13:15:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Penicillin allergyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-10-2020 13:15:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1984Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-10-2020 13:15:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae401a\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-2021-5683-0787504
Page 92 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-10-2020 13:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Generalized An
xiety
Start Date: Apr/UNK/2019
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-10-2020 13:15:27
(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-10-2020 13:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Generalized AnxietyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-10-2020 13:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-10-2020 13:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae401a\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-2021-5683-0787505
Page 93 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-10-2020 13:15:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-10-2020 13:15:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
189.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-10-2020 13:15:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-10-2020 13:15:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
64.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-10-2020 13:15:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-10-2020 13:15:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
32.5Initial Entry
090177e196ae401a\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) (6)
(b) (4)
FDA-CBER-2021-5683-0787506
Page 94 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a
Date Location User Value Reason
Aug-10-2020 13:15:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.2
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-10-2020 13:15:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-10-2020 13:15:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-10-2020 13:15:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-10-2020 13:15:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae401a\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) (6)
(b) (4)
FDA-CBER-2021-5683-0787507
Page 95 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-10-2020 13:16:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-10-2020 13:16:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-10-2020 13:16:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-10-2020 13:16:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-10-2020 13:16:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-10-2020 13:16:07
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787508
Page 96 of 156
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-10-2020 13:16:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-10-2020 13:16:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-10-2020 13:16:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787509
Page 97 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-10-2020 13:16:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-10-2020 13:16:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
45557Initial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787510
Page 98 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-10-2020 14:11:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-10-2020 14:11:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-10-2020 14:11:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-10-2020 14:11:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-10-2020 14:11:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/10/2020Initial Entry
5.a
Date Location User Value Reason
Aug-10-2020 14:11:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP6P9FInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787511
Page 99 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-10-2020 14:11:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP6P9FInitial Entry
5.b
Date Location User Value Reason
Aug-10-2020 14:11:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP6P9GInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-10-2020 14:11:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP6P9GInitial Entry
5.c
Date Location User Value Reason
Aug-10-2020 14:11:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP6P9HInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-10-2020 14:11:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP6P9HInitial Entry
5.d
Date Location User Value Reason
Aug-10-2020 14:11:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPG6H0Initial Entry
090177e196ae401a\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) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787512
Page 100 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Aug-10-2020 14:11:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPG6H0Initial Entry
5.e
Date Location User Value Reason
Aug-10-2020 14:11:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPG6H1Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-10-2020 14:11:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPG6H1Initial Entry
090177e196ae401a\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-2021-5683-0787513
Page 101 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-10-2020 14:34:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-10-2020 14:34:22
(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-10-2020 14:34:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-10-2020 14:34:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-10-2020 14:34:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/10/2020Initial Entry
5.a
Date Location User Value Reason
Aug-10-2020 14:34:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP6P9PInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787514
Page 102 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-10-2020 14:34:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP6P9PInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787515
Page 103 of 156
***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: 10181111 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-10-2020 13:16:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-10-2020 13:16:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-10-2020 13:16:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-10-2020 13:16:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020 12:22Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-10-2020 13:16:55
(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-10-2020 13:16:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae401a\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-2021-5683-0787516
Page 104 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7. Route:
Date Location User Value Reason
Aug-10-2020 13:16:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-10-2020 13:16:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-10-2020 13:16:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787517
Page 105 of 156
***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: 10181111 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-10-2020 13:17:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-D
IARY COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787518
Page 106 of 156
***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: 10181111 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-01-2020 16:48:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787519
Page 107 of 156
***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: 10181111 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-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-01-2020 16:48:32
(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-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae401a\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) (6)
(b) (4)
FDA-CBER-2021-5683-0787520
Page 108 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
GU
E
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-01-2020 16:48:32
(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-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae401a\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-2021-5683-0787521
Page 109 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.c Symptom:
Date Location User Value Reason
Sep-01-2020 16:48:32
(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-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-01-2020 16:48:32
(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-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae401a\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) (6)
(b) (4)
FDA-CBER-2021-5683-0787522
Page 110 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-01-2020 16:48:32
(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-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae401a\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)
FDA-CBER-2021-5683-0787523
Page 111 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.f Symptom:
Date Location User Value Reason
Sep-01-2020 16:48:32
(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-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae401a\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) (6)
(b) (4)
FDA-CBER-2021-5683-0787524
Page 112 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae401a\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)
FDA-CBER-2021-5683-0787525
Page 113 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae401a\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)
FDA-CBER-2021-5683-0787526
Page 114 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 16:48:32
(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-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 16:48:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae401a\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) (6)
(b) (4)
FDA-CBER-2021-5683-0787527
Page 115 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020 16:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
2.a
Date Location User Value Reason
Sep-01-2020 16:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 96.8
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-01-2020 16:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-02-2020 02:12:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as per site
response.
Sep-01-2020 16:49:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered PER SOURCE NO
CLINICAL
SIGNIFICANCE
Sep-01-2020 16:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 96.8 F
is outside of Normal
Range 97 - 99.5 F.
090177e196ae401a\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) (6)
(b) (4)
FDA-CBER-2021-5683-0787528
Page 116 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-01-2020 16:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
96.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-01-2020 16:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-01-2020 16:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae401a\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-2021-5683-0787529
Page 117 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-01-2020 16:49:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-01-2020 16:49:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-01-2020 16:49:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-01-2020 16:49:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-01-2020 16:49:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-01-2020 16:49:31
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787530
Page 118 of 156
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-01-2020 16:49:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-01-2020 16:49:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-01-2020 16:49:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787531
Page 119 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 16:49:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 16:49:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 16:49:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-01-2020 16:49:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-01-2020 16:49:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 16:49:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN5NP6Initial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787532
Page 120 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 16:49:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN5NP6Initial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787533
Page 121 of 156
***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: 10181111 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
Sep-01-2020 16:50:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020 16:50:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020 16:50:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-01-2020 16:50:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020 13:19Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020 16:50:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-01-2020 16:50:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae401a\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-2021-5683-0787534
Page 122 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7. Route:
Date Location User Value Reason
Sep-01-2020 16:50:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-01-2020 16:50:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-01-2020 16:50:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787535
Page 123 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020 15:55:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Oct/6/2020Initial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787536
Page 124 of 156
***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: 10181111 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
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Symptom:: FA
TIInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787537
Page 125 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NO
2.b Symptom:
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787538
Page 126 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.c Symptom:
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787539
Page 127 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Symptom:: VO
MIT
ING
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787540
Page 128 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.f Symptom:
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
NEW OR WORSENED MUSC
LE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
NOInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787541
Page 129 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Symptom:: NEW O
R WORS
ENED J
OINT PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
NEW OR WORSENED JOINT
PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-06-2020 15:55:35
(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
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
LEFTInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787542
Page 130 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787543
Page 131 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on the
last day the Subject
Diary was completed
?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020 15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
NOInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787544
Page 132 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020 15:56:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020 15:56:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020 15:56:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-06-2020 15:56:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-06-2020 15:56:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
YES
Date of Collection:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020 15:56:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Sample ID: BP9FVFInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787545
Page 133 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Oct-06-2020 15:56:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
BP9FVFInitial Entry
5.b
Date Location User Value Reason
Oct-06-2020 15:56:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Sample ID: BP9FVGInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-06-2020 15:56:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
BP9FVGInitial Entry
5.c
Date Location User Value Reason
Oct-06-2020 15:56:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Sample ID: BLB3N7Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-06-2020 15:56:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
BLB3N7Initial Entry
5.d
Date Location User Value Reason
Oct-06-2020 15:56:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Sample ID: BLB3N8Initial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787546
Page 134 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Oct-06-2020 15:56:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
BLB3N8Initial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787547
Page 135 of 156
***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: 10181111 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
Oct-06-2020 15:56:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
Oct/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-06-2020 15:56:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-06-2020 15:56:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 William
FernandezData Entry:
COMPLETEDInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787548
Page 136 of 156
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 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-12-2021 17:00:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-23-2021 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Feb-22-2021 09:40:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-12-2021 17:00:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Feb-23-2021 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Feb-22-2021 09:40:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Mar-12-2021 17:00:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Feb-23-2021 16:19:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Feb-22-2021 09:40:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PREGNANCYInitial Entry
090177e196ae401a\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) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787549
Page 137 of 156
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4. Specify Status:
Date Location User Value Reason
Mar-12-2021 17:00:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787550
Page 138 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Jan-19-2021 15:07:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787551
Page 139 of 156
***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
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Jan-19-2021 15:07:50
(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-19-2021 15:07:50
(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
Feb-03-2021 18:14:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Feb-01-2021 16:56:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Will updated SAE
form and fax in.
Jan-30-2021 22:08:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical Please
submit a Safety
update for
contraceptive method
in use; or stop date of
prior contraceptive
method in study
Jan-29-2021 12:09:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed SDB updated
Jan-26-2021 08:33:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Candidate Pending SDB update
Jan-25-2021 09:59:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Form was updated
090177e196ae401a\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) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787552
Page 140 of 156
***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
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-24-2021 20:19:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE RECON:
AER#2021021796,
the term in SDB was
reported as
Pregnancy, please
confirm if a follow up
AEM form was
submitted to update
term to Exposure
during pregnancy.
Jan-20-2021 21:21:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-20-2021 16:37:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered AEM form will be
updated to reflect
term
Jan-20-2021 06:43:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CON:
AER#2021021796,
the term in SDB was
reported as Pregnancy
while in Inform it was
updated to Exposure
during pregnancy.
Please confirm if a
follow up AEM form
was submitted to
update term in Safety
database.
Jan-19-2021 15:07:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exposure during PregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-08-2021 22:28:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Feb-05-2021 09:05:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Subject was
contacted, LMP was
11DEC2020 as
noted
090177e196ae401a\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) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787553
Page 141 of 156
***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
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-02-2021 17:39:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Reissued:Opened Clinical Thank you;
please try to confirm
with subject that 1st
day of LMP was
11Dec20 (>14 days
after conception)
Feb-01-2021 16:53:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Per the subjects
verbal report from
OB-gyn. The
ultrasound showed
date of conception
was estimated to be
24Nov2020.
Jan-30-2021 22:06:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical Estimated
date of conception is
24Nov20; however,
SAE report that 1st
day of LMP was
after this (on
11Dec20). Please
confirm dates; could
LMP be 12Nov20?
Jan-30-2021 22:03:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Jan-27-2021 14:21:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Form will be
updated
Jan-27-2021 12:54:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINICAL
Followup: Event
start date is
24Nov20 (estimated
date of conception);
however, SAE
report event start
date is still 09Jan21
(+ urine PG test
date). Please update
SAE event start
date. Clarify
conception date
prior to 1st day of
LMP (11Dec20).
090177e196ae401a\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) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787554
Page 142 of 156
***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
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-20-2021 21:20:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Query closed; will
follow for SAE
update with the
requested Updated
start date info
Jan-20-2021 16:36:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Jan-20-2021 16:36:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/24/2020 UNK:UNKChanged
Information
Jan-20-2021 07:29:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL For
conception date
[Start Date],
ultrasound
measurement of the
fetus in first
trimester is the most
accurate method; in
the absence of US,
the 1st day of the
last menstrual
period (LMP)
should be used to
estimate conception;
update in AE/SAE
Jan-19-2021 15:07:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/9/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-23-2021 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-22-2021 09:40:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is
still ongoing. Please
review and update as
appropriate.
090177e196ae401a\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)
FDA-CBER-2021-5683-0787555
Page 143 of 156
***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
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-19-2021 15:07:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-20-2021 21:21:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-20-2021 15:17:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-20-2021 15:17:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-20-2021 15:17:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Jan-20-2021 07:25:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical As per CRF
CG 8.50.2.5, the
toxicity grade for
“Exposure During
Pregnancy” is
reported as Not
Applicable
Jan-19-2021 15:07:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial 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-24-2021
20:20:39
(UTC-06:00) CentralACV0PFEINFP6000 Query 2: Closed Response satisfies query
090177e196ae401a\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) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787556
Page 144 of 156
***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
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
Jan-21-2021
11:44:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Updated per 8.50.2.5 CRF
Jan-21-2021
11:44:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOUpdated per 8.50.2.5 CRF
Jan-20-2021
21:23:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Open
edCLINICAL As per CRF
Completion Guidelines 8.50.2.5,
an “Exposure During
Pregnancy” is NOT an SAE
[despite using similar forms to
report pregnancy]; only
abnormal outcomes of
pregnancy are evaluated for
serious criteria
Jan-20-2021
16:45:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Per reporting guidelines this is
considered SAE please advise
further?
Jan-20-2021
06:45:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE RECON:
AER#2021021796,'EXPOSURE
DURING PREGNANCY' event
was appropriately reported to
safety; however, seriousness
criteria is met there is an
abnormal pregnancy
outcome/protocol section
8.3.5.1. Please update
seriousness criteria accordingly.
Jan-20-2021
06:44:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted Query can be addressed
internally
Jan-19-2021
15:07:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Exposure during
Pregnancy: Response to "Is the
adverse event serious?" is 'Yes'
but "Serious Adverse Event
Number" is blank.
090177e196ae401a\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) (6)
(b) (4)
FDA-CBER-2021-5683-0787557
Page 145 of 156
***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
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-19-2021
15:07:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event ass
ociated with congenital
anomaly or birth defect
?
NO
Did this serious event r
esult in death?
NO
Did this serious event r
equire or prolong hospi
talization?
NO
Did this serious event r
esult in persistent or si
gnificant disability/inc
apacity?
NO
Is this serious event lif
e threatening?
NO
Other medically import
ant serious event
YESInitial Entry
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.
Date Location User Value Reason
Jan-19-2021 15:07:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787558
Page 146 of 156
***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
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Jan-20-2021 21:25:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Query closed; will
follow for SAE
update with the
requested (lack of)
contraception info
Jan-20-2021 16:44:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Form will be
updated.
Jan-20-2021 07:36:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - Please
submit a safety
update reporting the
pregnancy occurred
following
unprotected sexual
activity; e.g., no
contraception was
being used.
Jan-19-2021 15:07:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
Unprotected sexual activit
yInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-19-2021 15:07:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae401a\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) (6)
(b) (4)
FDA-CBER-2021-5683-0787559
Page 147 of 156
***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
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-19-2021 15:07:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-19-2021 15:07:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-21-2021 04:01:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Jan-21-2021 03:20:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-20-2021 16:39:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Changed data per
query
Jan-20-2021 16:39:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE Exposure
during Pregnancy:
Response to "What
was the outcome of
this adverse event?" is
'Unknown' but End
Date/Time is provided
or "Is the adverse
event still ongoing?"
is marked "Yes".
Jan-20-2021 16:39:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
090177e196ae401a\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) (6)
(b) (4)
FDA-CBER-2021-5683-0787560
Page 148 of 156
***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
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-20-2021 16:39:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNKNOWNChanged Information
Jan-20-2021 06:40:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2021021796,
the outcome in AE
CRF was reported as
NOT
RECOVERED/NOT
RESOLVED. Per 3
Nov EDP guidance
(study
communication),
outcome should be
recorded as
UNKNOWN. Please
confirm and update
accordingly.
Jan-19-2021 15:07:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-19-2021 15:07:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae401a\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)
FDA-CBER-2021-5683-0787561
Page 149 of 156
***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: 10181111 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-16-2021 13:46:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021Initial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787562
Page 150 of 156
***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: 10181111 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-16-2021 13:47:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT willing to return
for Vaccination 3 OR otherwise not
eligibleInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787563
Page 151 of 156
***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: 10181111 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-16-2021 13:46:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Feb-26-2021
04:14:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedResponse satisfies
query
Feb-25-2021
15:33:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dAs per protocol
amenndment 12 : "
Instructions on how to
unblind participants
ahead of administration
of BNT162b2 to
placebo recipients will
be provided separately:
this unblinding will
NOT be performed in
the IRT."
Feb-25-2021
10:16:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Op
enedIVRS Reconciliation:
Other is selected as the
primary reason for
unblinding but
matching blind break is
not captured in IRT.
Please correct primary
reason in Inform or
confirm as correct”.
Feb-23-2021
21:14:09
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_35
090177e196ae401a\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-2021-5683-0787564
Page 152 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Canada)
Feb-23-2021
16:18:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dClarify
Feb-23-2021
16:18:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
OTH
ER
If ot
her,
spec
ify:
Pat
ien
t te
ste
d p
osi
tiv
e f
or
pre
gn
an
cy.Clarify
Feb-22-2021
16:36:09
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM: REVAX CONF
page unfrozen for data
update. Thank you.
Feb-22-2021
09:47:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dplease unfreeze
Feb-22-2021 ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY QueryDMW7348571;Primary
090177e196ae401a\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-2021-5683-0787565
Page 153 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
00:38:02
(UTC-06:00)
Central Time
(US &
Canada)1: Op
enedReason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Jan-16-2021
13:46:07
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
ASSE
SS EL
IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ONInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787566
Page 154 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Feb-23-2021 16:19:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPTranscription Error
Feb-22-2021 09:40:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-06-2020 15:56:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-10-2020 13:16:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-10-2020 13:14:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-23-2021 16:19:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/6/2020Transcription Error
Feb-23-2021 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/6/2020Transcription Error
Feb-22-2021 09:40:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Jan/6/2021Initial Entry
Jan-20-2021 11:02:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-19-2021 15:08:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787567
Page 155 of 156
***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: 10181111 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-13-2021 10:49:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical Please enter
the event Pregnancy
on the AE log,
following CRF
completion
guidelines in Sect
8.50.2.5
Oct-06-2020 15:56:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/6/2020Initial Entry
Aug-10-2020 13:16:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/10/2020Initial Entry
Aug-10-2020 13:14:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/10/2020Initial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787568
Page 156 of 156
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 10181111 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 16:42:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae401a\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787569