125742 S1 M5 CRF c4591001 1036 10361140

Document text

Page 1 of 150
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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 version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787989
Page 2 of 150
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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
Oct/22/2020
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787990
Page 3 of 150
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10361140]
2.Birth Date: /1956
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787991
Page 4 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787992
Page 5 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787993
Page 6 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/22/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787994
Page 7 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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:[ringing in the left ear; tinnitus]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/1995
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Barrett's esophagus]
Start Date: UNK/UNK/1998
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[seasonal allergies]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787995
Page 8 of 150
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[scoliousis of the spine]
Start Date: UNK/UNK/2010
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[back surgery]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[back pain]
Start Date: UNK/UNK/1996
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[urination frequency]
Start Date: UNK/UNK/2005
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[trouble sleeping]
Start Date: UNK/UNK/1989
Ongoing: YES
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787996
Page 9 of 150
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypercholesterolemia]
Start Date: UNK/UNK/1995
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteoarthritis]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787997
Page 10 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787998
Page 11 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/22/2020
2.Weight: [235.0]
3.Unit: LB
4.Height: [74.0]
5.Unit: in
6.Body Mass Index: [30.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787999
Page 12 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/22/2020
2.Randomization Number: [271515]
3.Randomization Group: [ ]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788000
Page 13 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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/22/2020
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 [BPWHDB]
5.bSample ID [BNWFRB]
5.cSample ID [BNWFRC]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788001
Page 14 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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:
Oct/22/2020
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 [BPWHDC]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788002
Page 15 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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: Oct/22/2020 14:46
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
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788003
Page 16 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788004
Page 17 of 150
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788005
Page 18 of 150
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Nov/12/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788006
Page 19 of 150
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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:
Nov/12/2020
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 [BPWHGT]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788007
Page 20 of 150
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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: Nov/12/2020 13:50
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
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788008
Page 21 of 150
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/10/2020
2.Erroneous Visit
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788009
Page 22 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/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 [BPWHJT]
5.bSample ID [BNWFXG]
5.cSample ID [BNWFXH]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788010
Page 23 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788011
Page 24 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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 [ ]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788012
Page 25 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788013
Page 26 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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 [ ]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788014
Page 27 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788015
Page 28 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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 [ ]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788016
Page 29 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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:
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788017
Page 30 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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: [ ]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788018
Page 31 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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 [ ]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788019
Page 32 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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 [ ]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788020
Page 33 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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?
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788021
Page 34 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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:
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788022
Page 35 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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:
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788023
Page 36 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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 [ ]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788024
Page 37 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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:
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788025
Page 38 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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 [ ]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788026
Page 39 of 150
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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  Traumatic Injuries
 Feb/10/2021 UNK
:UNK NO
End Date Time:
Feb/10/2021 UNK:UNK
 Repeating
Pages
 2.ADVERSE EV
ENT 2  Motor Vehicle Ac
cident Feb/10/2021 UNK
:UNK NO
End Date Time:
Feb/10/2021 UNK:UNK
 Repeating
Pages
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788027
Page 40 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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)[Traumatic Injuries]
4.Start Date Time: Feb/10/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/10/2021 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788028
Page 41 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[car accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from
the study?YES
15.Serious Adverse Event Number:
For Pfizer Use Only[2021218999]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788029
Page 42 of 150
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Motor Vehicle Accident]
4.Start Date Time: Feb/10/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/10/2021 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788030
Page 43 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT NON-DRUG TREATMENT
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from
the study?YES
15.Serious Adverse Event Number:
For Pfizer Use Only[2021218999]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788031
Page 44 of 150
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788032
Page 45 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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[ ]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788033
Page 46 of 150
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788034
Page 47 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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: //
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788035
Page 48 of 150
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788036
Page 49 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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?
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788037
Page 50 of 150
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788038
Page 51 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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?
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788039
Page 52 of 150
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788040
Page 53 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788041
Page 54 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788042
Page 55 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788043
Page 56 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788044
Page 57 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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:
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788045
Page 58 of 150
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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?
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788046
Page 59 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788047
Page 60 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788048
Page 61 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788049
Page 62 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788050
Page 63 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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 [ ]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788051
Page 64 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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 [ ]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788052
Page 65 of 150
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/10/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788053
Page 66 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788054
Page 67 of 150
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination
1/2
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788055
Page 68 of 150
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death :Feb/10/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788056
Page 69 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788057
Page 70 of 150
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788058
Page 71 of 150
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification
of Death:Feb/10/2021
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [motor vehicle collision]
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788059
Page 72 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Feb/10/2021
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788060
Page 73 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788061
Page 74 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788062
Page 75 of 150
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-22-2020 15:38:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788063
Page 76 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormMar-10-2021 10:18:39 (UTC-06:00) Central
Time (US & Canada)This AE is already reported as an SAE under
Traumatic Injuries. Query wanted me to split
the term.
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788064
Page 77 of 150
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-23-2021 14:43:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788065
Page 78 of 150
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-23-2021 14:43:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788066
Page 79 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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-11-2021 10:51:42 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Marcus Lee  Approved Jan-22-2021 09:09:55 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MarcusLee, 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.
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788067
Page 80 of 150
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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
Oct-22-2020 15:36:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-22-2020 15:36:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788068
Page 81 of 150
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-22-2020 15:37:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Oct/22/2020Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788069
Page 82 of 150
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-22-2020 15:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10361140Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-22-2020 15:36:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1956Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-22-2020 15:37:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-22-2020 15:37:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-22-2020 15:37:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788070
Page 83 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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-22-2020 15:38:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788071
Page 84 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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-22-2020 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-22-2020 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-22-2020 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788072
Page 85 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Oct-23-2020 10:12:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH N
umber:1
Medical His
tory Term:ringing in the l
eft ear; tinnitus
Start Date: UNK/UNK/20
15
Ongoing: YESTranscription Error
Oct-22-2020 15:40:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:ringing in th
e left ear
Start Date: UNK/UNK/
2015
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:40:09
(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
Oct-23-2020 10:12:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ringing in the left ear; tinnitu
sTranscription Error
Oct-22-2020 15:40:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ringing in the left earInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788073
Page 86 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.a Start Date:
Date Location User Value Reason
Oct-22-2020 15:40:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-22-2020 15:40:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-22-2020 15:40:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:hypertension
Start Date: UNK/UNK/1
995
Ongoing: YESInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788074
Page 87 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:40:39
(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
Oct-22-2020 15:40:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
hypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-22-2020 15:40:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-22-2020 15:40:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-22-2020 15:41:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:Barrett's esop
hagus
Start Date: UNK/UNK/1
998
Ongoing: YESInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788075
Page 88 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:41:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020 15:41:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Barrett's esophagusInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-22-2020 15:41:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-22-2020 15:41:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-22-2020 15:41:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:seasonal aller
gies
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788076
Page 89 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:41:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020 15:41:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
seasonal allergiesInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-22-2020 15:41:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-22-2020 15:41:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-23-2020 10:09:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:5
Medical Hist
ory Term:scoliousis of
the spine
Start Date: UNK/UNK/
2010
Ongoing: YESTranscription Error
Oct-22-2020 15:43:03 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788077
Page 90 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)(autocalc) Line/MH Num
ber:5
Medical Histor
y Term:sclerosis
Start Date: UNK/UNK
/2010
Ongoing: YES
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788078
Page 91 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:43:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Oct-23-2020
15:12:00
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
1: Clo
sedDiscrepancy has been
closed.
Oct-23-2020
10:09:53
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription Error
Oct-23-2020
10:09:53
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
scolio
usis o
f the s
pineTranscription Error
Oct-22-2020
23:13:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
1: Op
enedClarify as
follows..SCLEROSIS.
Are you reporting
ARTERIOSCLEROSIS
? or OTOSCLEROSIS
? or MULTIPLE
SCLEROSIS ? or else?
Please specify. Thank
you.
Oct-22-2020
15:43:03
(UTC-06:00)ACV0PFEINFP6000  Data
Entry
:Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0788079
Page 92 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time
(US &
Canada)sclero
sis
1.e Start Date:
Date Location User Value Reason
Oct-22-2020 15:43:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-22-2020 15:43:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-22-2020 15:43:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical History
Term:back surgery
Start Date: UNK/UNK/19
90
Ongoing: NO
End Date:
UNK/UNK/
1990Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788080
Page 93 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:43:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020 15:43:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
back surgeryInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-22-2020 15:43:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-22-2020 15:43:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
1.g
Date Location User Value Reason
Oct-22-2020 15:44:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:back pain
Start Date: UNK/UNK/1
996
Ongoing: YESInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788081
Page 94 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:44:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020 15:44:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
back painInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-22-2020 15:44:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1996Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-22-2020 15:44:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Oct-22-2020 15:45:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:8
Medical History
Term:urination freq
uency
Start Date: UNK/UNK/2
005
Ongoing: YESInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788082
Page 95 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:45:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020 15:45:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
urination frequencyInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-22-2020 15:45:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-22-2020 15:45:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Oct-22-2020 15:46:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History
Term:trouble sleepi
ng
Start Date: UNK/UNK/1
989
Ongoing: YESInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788083
Page 96 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:46:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020 15:46:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
trouble sleepingInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788084
Page 97 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.i Start Date:
Date Location User Value Reason
Oct-22-2020 15:46:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1989Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-22-2020 15:46:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Oct-22-2020 15:49:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:10
Medical History
Term:hypercholester
olemia
Start Date: UNK/UNK/19
95
Ongoing: YESInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788085
Page 98 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:49:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020 15:49:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
hypercholesterolemiaInitial Entry
1.j Start Date:
Date Location User Value Reason
Oct-22-2020 15:49:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-22-2020 15:49:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Oct-23-2020 10:13:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:11
Medical History
Term:osteoarthritis
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788086
Page 99 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.k Line/MH Number:
Date Location User Value Reason
Oct-23-2020 10:13:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 10:13:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
osteoarthritisInitial Entry
1.k Start Date:
Date Location User Value Reason
Oct-23-2020 10:13:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.k Ongoing:
Date Location User Value Reason
Oct-23-2020 10:13:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788087
Page 100 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-22-2020 15:51:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to
be HIV POSITIVEInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788088
Page 101 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-22-2020 15:52:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-22-2020 15:52:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
235.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-22-2020 15:52:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-22-2020 15:52:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
74.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-22-2020 15:52:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0788089
Page 102 of 150
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-22-2020 15:52:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.2Initial Entry
7.a
Date Location User Value Reason
Oct-22-2020 15:52:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 98.3
Temperature Uni
t:F
Temperature Loc
ation::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-22-2020 15:52:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-22-2020 15:52:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-22-2020 15:52:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788090
Page 103 of 150
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-22-2020 15:52:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788091
Page 104 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-22-2020 15:52:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-22-2020 15:52:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
271515Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788092
Page 105 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 16:32:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 16:32:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 16:32:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 16:32:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-22-2020 16:32:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020 16:32:17 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0788093
Page 106 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)Sample ID: BPWHDB
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 16:32:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPWHDBInitial Entry
5.b
Date Location User Value Reason
Oct-22-2020 16:32:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWFRBInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020 16:32:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNWFRBInitial Entry
5.c
Date Location User Value Reason
Oct-22-2020 16:32:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWFRCInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020 16:32:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNWFRCInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0788094
Page 107 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 16:33:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 16:33:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 16:33:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 16:33:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-22-2020 16:33:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020 16:33:56 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0788095
Page 108 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)Sample ID: BPWHDC
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 16:33:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPWHDCInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788096
Page 109 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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
Oct-22-2020 15:53:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-22-2020 15:53:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-22-2020 15:53:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-22-2020 15:53:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020 14:46Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-22-2020 15:53:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788097
Page 110 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-22-2020 15:53:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-22-2020 15:53:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-22-2020 15:53:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-22-2020 15:53:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788098
Page 111 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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
Oct-22-2020 15:53:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED
FOR THIS SUBJECTInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788099
Page 112 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-12-2020 14:31:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/12/2020Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788100
Page 113 of 150
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Nov-12-2020 14:31:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/12/2020Initial Entry
2.a
Date Location User Value Reason
Nov-12-2020 14:31:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 97.4
Temperature Uni
t:F
Temperature Loc
ation::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-12-2020 14:31:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-12-2020 14:31:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.4Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-12-2020 14:31:39
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0788101
Page 114 of 150
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
2.a Temperature Location:
Date Location User Value Reason
Nov-12-2020 14:31:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788102
Page 115 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-12-2020 14:32:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-12-2020 14:32:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-12-2020 14:32:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-12-2020 14:32:12
(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.
Nov-12-2020 14:32:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/12/2020Initial Entry
5.a
Date Location User Value Reason
Nov-12-2020 14:32:27 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0788103
Page 116 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)Sample ID: BPWHGT
5.a Sample ID
Date Location User Value Reason
Nov-12-2020 14:32:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPWHGTInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788104
Page 117 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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
Nov-12-2020 14:33:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-12-2020 14:33:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-12-2020 14:33:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-12-2020 14:33:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/12/2020 13:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-12-2020 14:33:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788105
Page 118 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-12-2020 14:33:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-12-2020 14:33:12
(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
Nov-12-2020 14:33:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-12-2020 14:33:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788106
Page 119 of 150
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-10-2020 13:49:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/10/2020Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788107
Page 120 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-10-2020 14:11:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-10-2020 14:11:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-10-2020 14:11:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-10-2020 14:11:30
(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.
Dec-10-2020 14:11:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/10/2020Initial Entry
5.a
Date Location User Value Reason
Dec-10-2020 14:11:46 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0788108
Page 121 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)Sample ID: BPWHJT
5.a Sample ID
Date Location User Value Reason
Dec-10-2020 14:11:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPWHJTInitial Entry
5.b
Date Location User Value Reason
Dec-10-2020 14:12:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWFXGInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-10-2020 14:12:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNWFXGInitial Entry
5.c
Date Location User Value Reason
Feb-11-2021 10:51:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWFXHInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-11-2021 10:51:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNWFXHInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0788109
Page 122 of 150
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Feb-22-2021 15:45:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788110
Page 123 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-10-2021 10:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788111
Page 124 of 150
***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, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-22-2021 15:45:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-22-2021 15:45:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-12-2021
14:34:35
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: A
nsweredwill send new
information
today
Mar-12-2021
14:34:12
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: A
nsweredwill send new
information
today
Mar-12-2021
14:33:47
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 6: A
nsweredwill send new
information
today
Mar-11-2021
16:35:25
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 6: Re
issued:Open
edClinical - please
submit the
subject's med Hx
(from study
start) and Con
Meds in a SAE
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788112
Page 125 of 150
***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, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
safety update
Mar-11-2021
16:35:07
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Re
issued:Open
edClinical - thank
you, please
submit this
information
[subject was the
Driver] to the
SAE ASAP
Mar-11-2021
16:34:44
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: Re
issued:Open
edClinical - thank
you, please
submit this
information [no
autopsy] to the
SAE ASAP
Mar-11-2021
16:33:02
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 7: Cl
osedResponse
satisfies query
Mar-10-2021
11:55:24
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 5: Cl
osedDiscrepancy has
been closed.
Mar-10-2021
09:58:55
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 7: A
nsweredper query needed
to split term for
safety reason
Mar-10-2021
09:58:55
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6: A
nsweredper query needed
to split term for
safety reason
Mar-10-2021
09:58:55
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: A
nsweredper query needed
to split term for
safety reason
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0788113
Page 126 of 150
***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, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-10-2021
09:58:55
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: A
nsweredper query needed
to split term for
safety reason
Mar-10-2021
09:58:55
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: A
nsweredper query needed
to split term for
safety reason
Mar-10-2021
09:58:55
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
Traumatic I
njuriesper query needed
to split term for
safety reason
Mar-10-2021
09:01:07
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: Re
issued:Open
edClinical - thank
you, please
submit this
information to
the SAE ASAP
Mar-10-2021
09:00:40
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Re
issued:Open
edClinical - thank
you, please
submit this
information in a
SAE update
ASAP
Mar-10-2021
08:22:24
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: A
nsweredNo autopsy was
performed
Mar-10-2021
08:21:53
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: A
nsweredsubject was the
driver
Mar-09-2021
09:44:22
(UTC-06:00)
Central TimeACV0PFEINFP6000  Query 7: O
penedClinical - For
coding purposes,
please separate
the term on 2 AE
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0788114
Page 127 of 150
***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, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) lines [motor
vehicle accident;
traumatic
injuries]
Mar-04-2021
18:38:35
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: Re
issued:Open
edClinical please
clarify as soon as
possible if an
autopsy was
performed
(yes/no)
Mar-04-2021
18:36:24
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 5: Re
issued:Open
edClinical - Safety
for SAE
reporting is not
requiring a split
of the terms
Mar-04-2021
18:35:32
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Re
issued:Open
edClinical Please
specify if subject
was a driver, or a
passenger, in a
SAE safety
update
Mar-04-2021
18:34:41
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 6: O
penedClinical - please
submit the
subject's med Hx
(from study
start) and Con
Meds in a SAE
safety update
Mar-04-2021
14:20:41
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 5: A
nsweredAre you asking
for these three
terms to be split
into three
different adverse
events? I'm still
not clear what
you are asking
me to do.
Mar-04-2021
02:29:29
(UTC-06:00)
Central TimeACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 5: O
penedMultiple
concepts in the
term
TRAUMATIC
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0788115
Page 128 of 150
***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, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) INJURIES
FROM MOTOR
VEHICLE
COLLISION.
Please split the
term into
TRAUMATIC
INJURIES and
MOTOR
VEHICLE
COLLISION
and submit
separately.
Thank you.
Mar-03-2021
17:54:14
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 4: Cl
osedDiscrepancy has
been closed.
Mar-03-2021
14:36:33
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: A
nsweredSubject was
driver. Unknown
if autopsy was
performed.
Mar-03-2021
14:36:33
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
Traumatic I
njuries from
motor vehic
le collision.Subject was
driver. Unknown
if autopsy was
performed.
Mar-02-2021
17:33:32
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 4: O
penedMultiple
concepts in the
term
TRAUMATIC
INJURIES
FROM MOTOR
VEHICLE
COLLISION.
SUBJECT WAS
DRIVER. UNK
IF AUTOPSY
WAS
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0788116
Page 129 of 150
***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, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
PERFORMED..
Split the term
into
TRAUMATIC
INJURIES and
MOTOR
VEHICLE
COLLISION.
SUBJECT WAS
DRIVER. UNK
IF AUTOPSY
WAS
PERFORMED
and report as
separate entries.
Thank you.
Mar-02-2021
14:57:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Cl
osedDiscrepancy has
been closed.
Mar-02-2021
12:20:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: A
nsweredNew Information
Mar-02-2021
12:20:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: A
nsweredNew Information
Mar-02-2021
12:20:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: A
nsweredNew Information
Mar-02-2021
12:20:26
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
Traumatic I
njuries from
motor vehicNew Information
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0788117
Page 130 of 150
***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, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
le collision.
Subject was
driver. UN
K if autopsy
was perfor
med.
Mar-01-2021
09:01:24
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: O
penedClinical please
clarify as soon as
possible if an
autopsy was
performed
(yes/no)
Mar-01-2021
08:59:57
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: O
penedClinical Please
specify if subject
was a driver, or a
passenger, in a
SAE safety
update
Feb-23-2021
03:15:20
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: O
penedMultiple
concepts in the
term
TRAUMATIC
INJURIES
FROM MOTOR
VEHICLE
COLLISION.
Split the term
into
TRAUMATIC
INJURIES and
MOTOR
VEHICLE
COLLISION
and submit
separately.
Thank you.
Feb-22-2021
15:45:15
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
Traumatic I
njuries from
motor vehic
le collisionInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0788118
Page 131 of 150
***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, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4. Start Date Time:
Date Location User Value Reason
Feb-22-2021 15:45:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-22-2021 15:45:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/10/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-22-2021 15:55:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-01-2021 23:24:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed event reported in
SDB
Feb-24-2021 03:03:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE RECON:
Traumatic Injuries
from motor vehicle
collision is not
reported to Safety
database but
marked serious on
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0788119
Page 132 of 150
***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, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
AE CRF. Confirm
seriousness and
report to Pfizer
immediately. If this
event is not serious,
downgrade the
event on AE CRF
Feb-24-2021 03:01:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted Query can be
addressed
internally
Feb-22-2021 15:45:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Traumatic
Injuries from motor
vehicle collision:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Feb-22-2021 15:45:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result in
death?
YES
Did this serious event require
or prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabi
lity/incapacity?
NOInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788120
Page 133 of 150
***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, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Is this serious event life threat
ening?
NO
Other medically important ser
ious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-22-2021 15:45:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-22-2021 15:45:15
(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:
car accidentInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788121
Page 134 of 150
***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, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-22-2021 15:45:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-22-2021 15:45:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-22-2021 15:45:15
(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
Feb-22-2021 15:51:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-22-2021 15:45:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Response to "What
was the outcome of
this adverse
event?" is 'Fatal'
but Date of
Collection /
Notification of
Death on the Death
Details form is not
completed. Please
review and update
as appropriate.
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788122
Page 135 of 150
***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, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-22-2021 15:45:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FATALInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-02-2021 13:50:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Closed Response satisfies
query
Mar-02-2021 12:24:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Updated per query.
Feb-23-2021 05:01:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Opened CLINQUERY:
Please complete the
FUP tab for end of
study
Feb-22-2021 15:45:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-01-2021 23:22:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021218999Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0788123
Page 136 of 150
***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, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-10-2021 10:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-10-2021 10:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-10-2021 10:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Motor Vehicle AccidentInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-10-2021 10:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-10-2021 10:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/10/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788124
Page 137 of 150
***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, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Mar-10-2021 10:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-11-2021 04:25:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-10-2021 10:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Motor
Vehicle Accident:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Mar-10-2021 10:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
YES
Did this serious event require
or prolong hospitalization?
NOInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788125
Page 138 of 150
***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, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important seri
ous event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-10-2021 10:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-10-2021 10:16:46
(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:
CONCOMITANT NON-DR
UG TREATMENTInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-10-2021 10:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788126
Page 139 of 150
***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, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-10-2021 10:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-10-2021 10:16:46
(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
Mar-11-2021 16:30:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FATALTranscription Error
Mar-10-2021 10:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-12-2021 14:36:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered the injuries from
the car accident
caused death.
Mar-12-2021 03:43:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened Please review and
confirm which AE
caused subject to
discontinued from
study and update
data accordingly
Mar-11-2021 16:36:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0788127
Page 140 of 150
***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, Answered Queries
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-11-2021 16:30:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Changed data per
query
Mar-11-2021 16:30:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened More than 1 AE for
this patient has
"Did the adverse
event cause the
subject to be
discontinued from
the study?" marked
as 'Yes'.
Mar-11-2021 16:30:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Mar-11-2021 16:30:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESTranscription Error
Mar-11-2021 15:52:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY: 'Did
the adverse event
cause the subject to
be discontinued
from the study?' is
NO, however,
"motor vehicle
collision" is
reported as cause of
death on death
details. Please also
confirm that
outcome should be
FATAL.
Mar-10-2021 10:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-11-2021 04:25:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021218999Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0788128
Page 141 of 150
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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
Dec-10-2020 13:50:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-10-2020 13:50:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-10-2020 13:50:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788129
Page 142 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-23-2021 14:45:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/25/2021Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788130
Page 143 of 150
***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
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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
Feb-23-2021 14:45:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible and NOT confirmed
to have received only placeb
o at Vaccination 1/2Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788131
Page 144 of 150
***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, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 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-02-2021 12:21:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-02-2021 12:21:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Mar-02-2021 12:22:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-02-2021 12:21:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Response to
"Status" is
DEATH but
"Specify Status" is
Provided.
Mar-02-2021 12:21:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DEATHInitial Entry
4. Specify Status:
Date Location User Value Reason
Mar-02-2021 12:22:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Removed
information per
query.
Mar-02-2021 12:21:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Death from automobile acciden
t.Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788132
Page 145 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-23-2021 14:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/25/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-23-2021 14:43:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788133
Page 146 of 150
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Feb-23-2021 14:43:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788134
Page 147 of 150
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Mar-03-2021
05:52:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Site has updated the
Disposition follow up form.
Mar-02-2021
12:22:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Mar-02-2021
12:22:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021Transcription Error
Mar-02-2021
12:21:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Date of Collection /
Notification of Death is
greater than the Date of
Completion/Discontinuation
/Death on the Disposition
form 10/Feb/2021. Please
review and update as
appropriate
Mar-02-2021
12:18:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per query
Feb-23-2021
06:20:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Please consider to
update the FUP form.
Thank you.
Feb-22-2021
15:51:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/22/2021Initial Entry
2.a
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (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-2021-5683-0788135
Page 148 of 150
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Feb-22-2021 15:52:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cause of De
ath Status:PRIMARY CAU
SE OF DEATH
Cause of De
ath:motor vehicle col
lisionInitial Entry
2.a Cause of Death Status:
Date Location User Value Reason
Feb-22-2021 15:52:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CAUSE OF DEATHInitial Entry
2.a Cause of Death:
Date Location User Value Reason
Feb-22-2021 15:52:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
motor vehicle collisionInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788136
Page 149 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-02-2021 12:21:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Dec-10-2020 13:50:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-22-2020 15:52:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-22-2020 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-02-2021 12:21:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Feb/10/2021Initial Entry
Dec-10-2020 13:50:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/10/2020Initial Entry
Oct-22-2020 15:52:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
Oct-22-2020 15:38:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4)
FDA-CBER-2021-5683-0788137
Page 150 of 150
***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: 1036 Site Name: (1036) Trinity Clinical Research
Subject No: 10361140 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Jan-20-2021 15:54:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e7a\Final\Final On: 01-Apr-2021 04:54 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0788138