125742 S1 M5 CRF c4591001 1083 10831194

Document text

Page 1 of 162
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960815
Page 2 of 162
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/4/2020
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960816
Page 3 of 162
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Demography
1.Subject ID [10831194]
2.Birth Date: /1972
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:
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0960817
Page 4 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960818
Page 5 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960819
Page 6 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960820
Page 7 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic Rhinitis-Seasonal]
Start Date: UNK/UNK/2016
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: UNK/UNK/1986
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: Jan/UNK/2020
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sleep Apnea]
Start Date: UNK/UNK/2014
Ongoing: YES
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960821
Page 8 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
2.Weight: [273.2]
3.Unit: LB
4.Height: [72.5]
5.Unit: in
6.Body Mass Index: [36.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960822
Page 9 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/4/2020
2.Randomization Number: [81918]
3.Randomization Group: [ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960823
Page 10 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BPZ1N0]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960824
Page 11 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BPZ1N8]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960825
Page 12 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/4/2020 12:40
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
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960826
Page 13 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960827
Page 14 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960828
Page 15 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960829
Page 16 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
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 [BLCJWJ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960830
Page 17 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/23/2020 14:51
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
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960831
Page 18 of 162
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960832
Page 19 of 162
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [BP21WF]
5.bSample ID [BPHMSX]
5.cSample ID [BPHMSY]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960833
Page 20 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960834
Page 21 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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: [ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960835
Page 22 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960836
Page 23 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960837
Page 24 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960838
Page 25 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960839
Page 26 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960840
Page 27 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960841
Page 28 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960842
Page 29 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Unplanned Assessments
1.Assessments
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960843
Page 30 of 162
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/22/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960844
Page 31 of 162
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960845
Page 32 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960846
Page 33 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960847
Page 34 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  New Onset Atrial Fibrillation with ra
pid ventricular response Oct/26/202
0 00:00 YES  Repeating
Pages
 2.ADVERSE
EVENT 2  Chest Pain  Oct/26/202
0 00:00 NO
End Date Time:
Oct/28/2020 00:00
 Repeating
Pages
 3.ADVERSE
EVENT 3  Heart Palpitations  Oct/26/202
0 00:20 NO
End Date Time:
Oct/28/2020 00:00
 Repeating
Pages
 4.ADVERSE
EVENT 4  Trivial Mitral Regurgitation  Oct/26/202
0 00:00 YES  Repeating
Pages
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960848
Page 35 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[New Onset Atrial Fibrillation with rapid ventricular response]
4.Start Date Time: Oct/26/2020 00:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960849
Page 36 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:
[Arrhythmia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020427451]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960850
Page 37 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Chest Pain]
4.Start Date Time: Oct/26/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/28/2020 00:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Arrhythmia]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960851
Page 38 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960852
Page 39 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Heart Palpitations]
4.Start Date Time: Oct/26/2020 00:20
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/28/2020 00:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Arrhythmia]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960853
Page 40 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960854
Page 41 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Trivial Mitral Regurgitation]
4.Start Date Time: Oct/26/2020 00:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Heart Disease]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960855
Page 42 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960856
Page 43 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960857
Page 44 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960858
Page 45 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960859
Page 46 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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: //
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960860
Page 47 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960861
Page 48 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960862
Page 49 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960863
Page 50 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960864
Page 51 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960865
Page 52 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960866
Page 53 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960867
Page 54 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960868
Page 55 of 162
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960869
Page 56 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960870
Page 57 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960871
Page 58 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960872
Page 59 of 162
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960873
Page 60 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/14/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960874
Page 61 of 162
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960875
Page 62 of 162
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960876
Page 63 of 162
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960877
Page 64 of 162
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/22/2021
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960878
Page 65 of 162
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960879
Page 66 of 162
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/22/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960880
Page 67 of 162
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/22/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM3MB7]
5.bSample ID [BM3MB5]
5.cSample ID [BKN2FX]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960881
Page 68 of 162
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/22/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BKN2FG]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960882
Page 69 of 162
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/22/2021 09:16
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960883
Page 70 of 162
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960884
Page 71 of 162
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/12/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BKN2J6]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960885
Page 72 of 162
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/12/2021 09:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960886
Page 73 of 162
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960887
Page 74 of 162
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960888
Page 75 of 162
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960889
Page 76 of 162
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960890
Page 77 of 162
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960891
Page 78 of 162
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960892
Page 79 of 162
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960893
Page 80 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/22/2020
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960894
Page 81 of 162
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960895
Page 82 of 162
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Laurence Chu  Approved Mar-12-2021 09:13:40 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LaurenceChu, 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.
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960896
Page 83 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormSep-04-2020 17:28:20 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960897
Page 84 of 162
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormJan-22-2021 17:33:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960898
Page 85 of 162
***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, Signed, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Laurence Chu  Approved Mar-12-2021 09:13:40 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LaurenceChu, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-04-2021 10:43:47 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laurence Chu  Approved Jan-25-2021 09:50:06 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LaurenceChu, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-22-2021 17:33:03 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0960899
Page 86 of 162
***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, Signed, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Laurence Chu  Approved Jan-20-2021 18:28:09 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LaurenceChu, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-04-2020 14:33:14 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laurence Chu  Approved Nov-11-2020 09:52:47 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LaurenceChu, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-06-2020 15:33:53 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laurence Chu  Approved Nov-05-2020 14:25:38 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0960900
Page 87 of 162
***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, Signed, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Affidavit:
By my dated signature below, I, LaurenceChu, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-04-2020 16:35:27 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laurence Chu  Approved Oct-26-2020 14:08:09 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LaurenceChu, 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.
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0960901
Page 88 of 162
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-04-2020 17:24:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-04-2020 17:24:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960902
Page 89 of 162
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-04-2020 17:24:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Sep/4/2020Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960903
Page 90 of 162
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-04-2020 17:24:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10831194Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-04-2020 17:24:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1972Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-04-2020 17:24:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-04-2020 17:24:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-04-2020 17:24:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960904
Page 91 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-04-2020 17:26:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960905
Page 92 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-04-2020 17:28:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-04-2020 17:28:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-04-2020 17:28:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960906
Page 93 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.a
Date Location User Value Reason
Sep-04-2020 17:32:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Allergic Rhinitis
-Seasonal
Start Date: UNK/UNK/2016
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-04-2020 17:32:47
(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
Sep-04-2020 17:32:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Allergic Rhinitis-SeasonalInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-04-2020 17:32:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-04-2020 17:32:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960907
Page 94 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.b
Date Location User Value Reason
Sep-04-2020 17:33:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Obesity
Start Date: UNK/UNK/1
986
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-04-2020 17:33:56
(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
Sep-04-2020 17:33:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ObesityInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-04-2020 17:33:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1986Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-04-2020 17:33:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960908
Page 95 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Sep-04-2020 17:34:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Te
rm:Hypertensio
n
Start Date: Jan/UNK/20
20
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-04-2020 17:34:17
(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
Sep-04-2020 17:34:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-04-2020 17:34:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-04-2020 17:34:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-04-2020 17:34:40 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960909
Page 96 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-06:00) Central
Time (US & Canada)(autocalc) Line/MH Number
:4
Medical History T
erm:Sleep Apnea
Start Date: UNK/UNK/2
014
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-04-2020 17:34:40
(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
Sep-04-2020 17:34:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sleep ApneaInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-04-2020 17:34:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-04-2020 17:34:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960910
Page 97 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020 17:31:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-04-2020 17:31:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
273.2Initial Entry
3. Unit:
Date Location User Value Reason
Sep-04-2020 17:31:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-04-2020 17:31:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
72.5Initial Entry
5. Unit:
Date Location User Value Reason
Sep-04-2020 17:31:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-04-2020 17:31:21
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
36.5Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (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-2021-5683-0960911
Page 98 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-04-2020 17:31:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 98.1
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-04-2020 17:31:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-04-2020 17:31:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-04-2020 17:31:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-04-2020 17:31:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (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-2021-5683-0960912
Page 99 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-04-2020 17:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-04-2020 17:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
81918Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960913
Page 100 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 18:16:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 18:16:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020 18:16:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 18:16:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-04-2020 18:16:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020 18:16:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPZ1N0Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960914
Page 101 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 18:16:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPZ1N0Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960915
Page 102 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 18:15:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 18:15:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020 18:15:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 18:15:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-04-2020 18:15:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020 18:15:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPZ1N8Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960916
Page 103 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 18:15:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPZ1N8Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960917
Page 104 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-04-2020 17:29:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020 17:29:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020 17:29:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-04-2020 17:29:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020 12:40Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020 17:29:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-04-2020 17:29:33
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960918
Page 105 of 162
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-04-2020 17:29:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-04-2020 17:29:33
(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
Sep-04-2020 17:29:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960919
Page 106 of 162
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-04-2020 17:28:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960920
Page 107 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-23-2020 18:32:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0960921
Page 108 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date Location User Value Reason
Sep-23-2020 18:33:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
2.a
Date Location User Value Reason
Sep-23-2020 18:33:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 97.9
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-23-2020 18:33:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-23-2020 18:33:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-23-2020 18:33:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0960922
Page 109 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.a Temperature Location:
Date Location User Value Reason
Sep-23-2020 18:33:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0960923
Page 110 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020 18:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 18:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020 18:35:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 18:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-23-2020 18:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-25-2020 17:59:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLCJWJTranscription Error
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0960924
Page 111 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-23-2020 18:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLCJWHTranscription Error
Sep-23-2020 18:35:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: blcjwjInitial Entry
5.a Sample ID
Date Location User ValueReason
Sep-26-2020
08:01:08
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Sep-25-2020
17:59:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: An
swere
dTranscription Error
Sep-25-2020
17:59:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BLCJ
WJTranscription Error
Sep-25-2020
04:33:09
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Op
enedDMW4811490;The
Barcode BLCJWH is
recorded for two
subjects 10831189
and 10831194, Please
review and update as
appropriate.
Sep-23-2020
18:36:54
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Clo
sedClose Auto Query
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0960925
Page 112 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-23-2020
18:36:54
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BLCJ
WHTranscription Error
Sep-23-2020
18:35:42
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Op
enedBarcode contains
lower case letters
which is not the
correct format. Please
review and correct as
appropriate.
Sep-23-2020
18:35:42
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
blcjwjInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960926
Page 113 of 162
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-23-2020 18:38:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020 18:38:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020 18:38:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-23-2020 18:38:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020 14:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-23-2020 18:38:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-23-2020 18:38:15
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0960927
Page 114 of 162
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-23-2020 18:38:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-23-2020 18:38:15
(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
Sep-23-2020 18:38:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0960928
Page 115 of 162
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-05-2020
05:00:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed event downgraded in SDB
Nov-05-2020
00:43:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opene
dSAE RECON 1: ae#2
indicates CHEST PAIN as
the AE term however,
reported as non serious
while serious in Inform.
Please confirm event
seriousness. If safety
update is required, submit a
follow-up SAE Form.
Nov-04-2020
13:16:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Site will be receiving
medical records from
hospital and will review
and send a follow up report
by end of business day
Nov-04-2020
06:08:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020427451
Chest pain(onset
date:26Oct2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-22-2020 13:05:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (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-2021-5683-0960929
Page 116 of 162
***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, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 13:05:06
(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 13:05:06
(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 17:13:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 13:05:06
(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 13:05:06
(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 17:13:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP21WFInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0960930
Page 117 of 162
***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, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 17:13:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP21WFInitial Entry
5.b
Date Location User Value Reason
Dec-04-2020 14:33:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 
)Data Entry:
Sample ID: BPHMSXInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-04-2020 14:33:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPHMSXInitial Entry
5.c
Date Location User Value Reason
Dec-04-2020 14:33:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPHMSYInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-04-2020 14:33:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPHMSYInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0960931
Page 118 of 162
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-22-2020 13:05:18
(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 13:05:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-22-2020 13:05:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960932
Page 119 of 162
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Date Location User Value Reason
Nov-04-2020 16:35:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960933
Page 120 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Date Location User Value Reason
Nov-04-2020 16:38:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960934
Page 121 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Date Location User Value Reason
Nov-04-2020 16:40:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960935
Page 122 of 162
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Date Location User Value Reason
Nov-04-2020 16:41:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960936
Page 123 of 162
***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, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-04-2020 16:35:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-04-2020 16:35:27
(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
Nov-09-2020 12:07:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-09-2020 11:03:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Per PI NCS
Nov-05-2020 17:36:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL -SAE
report includes 3
platelet volume
results all elevated;
please submit the
rest of CBC
including platelet
count to the SAE,
as pertinent info.
Please consider
clinical
significance, and
report an event if
appropriate.
Nov-04-2020 16:35:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
New Onset Atrial Fibrillation w
ith rapid ventricular responseInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960937
Page 124 of 162
***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, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
4. Start Date Time:
Date Location User Value Reason
Nov-04-2020 16:35:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020 00:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021 06:18:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Juleen Gayed Query 1: Closed Response satisfies
query
Mar-04-2021 15:12:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Mar-04-2021 13:12:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Juleen Gayed Query 1: Opened Clin: Please
confirm if this AE
is still ongoing?
Nov-04-2020 16:35:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-05-2020 11:15:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Transcription Error
Nov-04-2020 16:35:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial 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
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (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)
(b) (4)
FDA-CBER-2021-5683-0960938
Page 125 of 162
***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, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Nov-07-2020 07:02:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Charu
SabharwalQuery 3: Closed Thanks - will close
query.
Nov-06-2020 15:29:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Good catch. Newest
SAE Follow Up
Letter #3 will have
the correct date.
Site has made
update to
previously sent
SAE follow up
letter source
Nov-06-2020 01:44:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened CLINICAL -
Injection #1 log
states performed on
04Sep20; however,
Injection date in
SAE report is
09Sep20. Please
review, and update
in the appropriate
location
Nov-05-2020 17:26:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Candidate CLINICAL -
Injection #1 log
states performed on
04Sep20; however,
Injection date in
SAE report is
09Sep20. Please
review, and update
in the appropriate
location
Nov-05-2020 11:02:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-05-2020 11:02:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NOTranscription Error
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0960939
Page 126 of 162
***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, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important ser
ious event
NO
Nov-05-2020 05:02:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-04-2020 16:35:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate For AE New Onset
Atrial Fibrillation
with rapid
ventricular
response: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Nov-04-2020 16:35:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Is the adverse event
serious?' is marked
as YES, but
responses to all of
the seriousness
criteria are NO. At
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960940
Page 127 of 162
***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, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
least one
seriousness
criterion is expected
to be YES for
serious events.
Please review and
update as
appropriate.
Nov-04-2020 16:35:27
(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 i
n death?
NO
Did this serious event require
or prolong hospitalization?
NO
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important ser
ious event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960941
Page 128 of 162
***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, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Nov-04-2020 16:35:27
(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
Nov-05-2020 11:15:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
ArrhythmiaNew Information
Nov-04-2020 16:37:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
.New Information
Nov-04-2020 16:35:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHERInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-04-2020 16:35:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (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-2021-5683-0960942
Page 129 of 162
***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, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Nov-07-2020 07:01:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Charu
SabharwalQuery 1: Closed Response satisfies
query
Nov-06-2020 15:35:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Conmedications
were given per
discharge medical
records but not
procedure was
needed
Nov-05-2020 17:31:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL SAE
report states that
subject's A fib
converted medically
(no cardioversion);
please review 'Con
Meds Given?' and
update, as
appropriate
Nov-04-2020 16:35:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-04-2020 16:35:27
(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
Nov-07-2020
09:43:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Nov-06-2020
15:33:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (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-2021-5683-0960943
Page 130 of 162
***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, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Nov-06-2020
15:33:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RE
SOLVINGNew Information
Nov-06-2020
05:01:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020427451,outcome
was reported as
Recovering/Resolving to Safety DB
however, recorded as NOT
RECOVERED/NOT RESOLVED
on AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Nov-04-2020
16:35:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERE
D/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-04-2020 16:35:27
(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
Nov-05-2020 05:02:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020427451Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (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-2021-5683-0960944
Page 131 of 162
***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, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-04-2020 16:38:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-04-2020 16:38:58
(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
Nov-09-2020 13:59:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ahmed Hassan Query 1: Closed Response satisfies
query
Nov-09-2020 10:43:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Symptom related to
SAE #1 Atrial
Fibrillation
Nov-06-2020 18:37:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Chest
Pain : Is a
diagnosis available
thanks
Nov-04-2020 16:38:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Chest PainInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-04-2020 16:38:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020 00:00Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0960945
Page 132 of 162
***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, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-04-2020 16:38:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/28/2020 00:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-05-2020 11:16:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Transcription Error
Nov-04-2020 16:38:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial 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
Nov-04-2020 16:38:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-04-2020 16:38:58
(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
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (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-2021-5683-0960946
Page 133 of 162
***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, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Nov-05-2020 11:16:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
ArrhythmiaNew Information
Nov-04-2020 16:38:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
.Initial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-04-2020 16:38:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-04-2020 16:38:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-04-2020 16:38:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (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-2021-5683-0960947
Page 134 of 162
***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, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Nov-04-2020 16:38:58
(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
Nov-04-2020 16:38:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960948
Page 135 of 162
***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, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-04-2020 16:40:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-04-2020 16:40:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-10-2020 04:02:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ahmed Hassan Query 1: Closed Response satisfies
query
Nov-09-2020 14:05:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Site waiting to hear
a response from
Certified letter
before updateing
FUP page
Nov-09-2020 14:00:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ahmed Hassan Query 1: Reissued:Opened if subject is not
responding to
contact, please
consider updating
the FUP page as
appropriate. thanks
Nov-09-2020 10:43:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Site has made
serveral attempts to
get subject to come
in. Certified letter
was sent
29OCT2020. Per
source subject
called 06NOV2020
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0960949
Page 136 of 162
***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, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
and LM site
returned call with
no answer. Site left
another message to
return call.
Nov-06-2020 18:37:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Heart
Palpitations: is a
diagnosis available?
Nov-04-2020 16:40:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Heart PalpitationsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-04-2020 16:40:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020 00:20Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-04-2020 16:40:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/28/2020 00:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-05-2020 11:18:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Transcription Error
Nov-04-2020 16:40:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (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-2021-5683-0960950
Page 137 of 162
***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, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
Nov-04-2020 16:40:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-04-2020 16:40:21
(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
Nov-05-2020 11:17:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
ArrhythmiaNew Information
Nov-04-2020 16:40:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
.Initial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960951
Page 138 of 162
***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, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Nov-04-2020 16:40:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-04-2020 16:40:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-04-2020 16:40:21
(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
Nov-04-2020 16:40:21
(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
Nov-04-2020 16:40:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (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-2021-5683-0960952
Page 139 of 162
***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, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-04-2020 16:41:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-04-2020 16:41:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-04-2020 16:41:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Trivial Mitral RegurgitationNew Information
Nov-04-2020 16:41:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Trivial Mitral RegurgitationsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-04-2020 16:41:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020 00:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-04-2020 16:41:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960953
Page 140 of 162
***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, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Nov-09-2020 14:00:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ahmed Hassan Query 1: Closed Response satisfies
query
Nov-09-2020 10:26:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original data is
correct per AE log
source sheet that
was assessed by PI.
Nov-06-2020 18:20:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Trivial
Mitral
Regurgitation:
Please can you
review the toxicity
grade of this AE as
currently it pertains
to 'does not interfere
with subjects' usual
function'. Thanks
Nov-05-2020 11:17:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1New Information
Nov-04-2020 16:41:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial 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
Nov-04-2020 16:41:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (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-2021-5683-0960954
Page 141 of 162
***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, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Nov-04-2020 16:42:31
(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
Nov-05-2020 11:18:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
Heart DiseaseNew Information
Nov-04-2020 16:41:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
.Initial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-04-2020 16:41:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-04-2020 16:41:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (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-2021-5683-0960955
Page 142 of 162
***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, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Nov-04-2020 16:41:39
(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
Nov-04-2020 16:41:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-04-2020 16:41:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960956
Page 143 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-14-2021 16:28:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/13/2021Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960957
Page 144 of 162
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-14-2021 16:28:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-14-2021 16:28:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-14-2021 16:28:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per local/national re
commendations and confirm
ed to have received only pla
cebo at Vaccination 1/2Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960958
Page 145 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-14-2021 16:28:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-14-2021 16:28:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960959
Page 146 of 162
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-22-2021 17:33:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960960
Page 147 of 162
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-22-2021 17:33:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Jan/22/2021Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960961
Page 148 of 162
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-22-2021 17:33:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-22-2021 17:33:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-22-2021 17:33:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960962
Page 149 of 162
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-22-2021 17:34:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-22-2021 17:34:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-22-2021 18:12:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-22-2021 17:34:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-22-2021 17:34:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/22/2021Initial Entry
5.a
Date Location User Value Reason
Jan-22-2021 18:12:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM3MB7Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960963
Page 150 of 162
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a Sample ID
Date Location User Value Reason
Jan-22-2021 18:12:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM3MB7Initial Entry
5.b
Date Location User Value Reason
Jan-22-2021 18:12:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM3MB5Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-22-2021 18:12:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM3MB5Initial Entry
5.c
Date Location User Value Reason
Jan-22-2021 18:12:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BKN2FXInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-22-2021 18:12:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BKN2FXInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (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-2021-5683-0960964
Page 151 of 162
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-22-2021 17:34:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-22-2021 17:34:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-22-2021 18:12:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-22-2021 17:34:52
(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.
Jan-22-2021 17:34:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/22/2021Initial Entry
5.a
Date Location User Value Reason
Jan-22-2021 18:12:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BKN2FGInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960965
Page 152 of 162
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a Sample ID
Date Location User Value Reason
Jan-22-2021 18:12:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BKN2FGInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960966
Page 153 of 162
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-22-2021 17:35:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-22-2021 17:35:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-22-2021 17:35:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-22-2021 17:35:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021 09:16Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-22-2021 17:35:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-22-2021 17:35:22
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960967
Page 154 of 162
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-22-2021 17:35:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-22-2021 17:35:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-22-2021 17:35:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-22-2021 17:35:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-22-2021 17:35:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960968
Page 155 of 162
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021 10:43:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/12/2021Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960969
Page 156 of 162
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-04-2021 10:48:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-04-2021 10:48:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-10-2021 10:23:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-05-2021 04:27:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Mar-04-2021 10:48:00
(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.
Mar-04-2021 10:48:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/12/2021Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960970
Page 157 of 162
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.a
Date Location User Value Reason
Mar-10-2021 10:23:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BKN2J6Initial Entry
5.a Sample ID
Date Location User Value Reason
Mar-10-2021 10:23:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BKN2J6Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960971
Page 158 of 162
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-04-2021 10:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-04-2021 10:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-04-2021 10:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Mar-04-2021 10:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/12/2021 09:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-04-2021 10:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-04-2021 10:48:59
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960972
Page 159 of 162
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
7. Route:
Date Location User Value Reason
Mar-04-2021 10:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Mar-04-2021 10:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-04-2021 10:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-04-2021 10:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Mar-04-2021 10:48:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960973
Page 160 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-11-2021 04:18:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-10-2021 14:23:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered V102 was
completed
12FEB2021
Mar-10-2021 09:16:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Rivkah Rosen Query 1: Reissued:Opened DM: Thank you for
your response.
V102 is entered as
occurring
12Feb2021. Can
you confirm
whether visit was
completed 12Feb or
06Mar? Thank you.
Mar-09-2021 23:43:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered V102 was
completed
06MAR2021 and
been entered
Mar-05-2021 02:30:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM Requery 1: As
per response, please
reschedule V102 on
6Mar2021 and
record the visit
details in inform.
Further, please
answer to this
query. Thank you.
Mar-04-2021 15:12:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Visit pushed OOW
due to inclement
weather and IP TE.
Visit V102 was
re-scheduled for
06MAR2021
Mar-04-2021 00:44:14
(UTC-06:00) CentralACV0PFEINFP6000  Query 1: Opened DM: V102 overdue
based on expected
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (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) (4)
FDA-CBER-2021-5683-0960974
Page 161 of 162
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada) visit window.
Please enter data or,
if visit will never
occur, mark Date of
Visit as Not Done
with form level
comment.
Oct-22-2020 13:05:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-04-2020 17:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-04-2020 17:28:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-22-2020 13:05:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
Sep-04-2020 17:30:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
Sep-04-2020 17:28:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960975
Page 162 of 162
***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, Signed, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-26-2020 13:50:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Laurence
ChuData Entry:
Click Here to EnableInitial Entry
090177e196ae3f98\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0960976