125742 S1 M5 CRF c4591001 1008 10081184

Document text

Page 1 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133099
Page 2 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/3/2020
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133100
Page 3 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10081184]
2.Birth Date: 1958
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:
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
FDA-CBER-2021-5683-0133101
Page 4 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/3/2020
2.Erroneous Visit
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133102
Page 5 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133103
Page 6 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133104
Page 7 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[High cholesterol]
Start Date: UNK/UNK/2019
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Thimerosal allergy]
Start Date: UNK/UNK/1974
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Elevated PSA]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133105
Page 8 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
2.Weight: [241.0]
3.Unit: LB
4.Height: [66.0]
5.Unit: in
6.Body Mass Index: [38.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133106
Page 9 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/3/2020
2.Randomization Number: [251769]
3.Randomization Group: [ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133107
Page 10 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/3/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPV0LL]
5.bSample ID [BPV0LM]
5.cSample ID [BPV0LN]
5.dSample ID [BRTY0N]
5.eSample ID [BRTY0P]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133108
Page 11 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/3/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTPR1]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133109
Page 12 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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/3/2020 14:32
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
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133110
Page 13 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133111
Page 14 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133112
Page 15 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Sep/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.2]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133113
Page 16 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/24/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BGK140]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133114
Page 17 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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/24/2020 10:57
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
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133115
Page 18 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133116
Page 19 of 146
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [BPZBHL]
5.bSample ID [BRZDFS]
5.cSample ID [BRZDFT]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133117
Page 20 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133118
Page 21 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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: [ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133119
Page 22 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133120
Page 23 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133121
Page 24 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133122
Page 25 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133123
Page 26 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133124
Page 27 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133125
Page 28 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133126
Page 29 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133127
Page 30 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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: [ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133128
Page 31 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133129
Page 32 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
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FDA-CBER-2021-5683-0133130
Page 33 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133131
Page 34 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Identif
ierAdverse Ev
entStart DateIs the Adverse Event Still O
ngoingForm Instance
 1.ADVERSE EVE
NT 1  Prostate can
cer Sep/30/2020 UNK:
UNK YES  Repeating
Pages
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133132
Page 35 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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)[Prostate cancer]
4.Start Date Time: Sep/30/2020 UNK:UNK
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?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133133
Page 36 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
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[2020412053]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133134
Page 37 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133135
Page 38 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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[ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133136
Page 39 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of MedicationStart
DateForm Instan
ce
 1.1  VACCINATI
ONS NO  Flucelvax influenza prophylaxis int
ramuscular vaccine 0.5 ml once Oct/19/
2020 Repeating
Pages
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133137
Page 40 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Flucelvax influenza prophylaxis intramuscular vaccine 0.5 ml once]
5.Date: Oct/19/2020
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FDA-CBER-2021-5683-0133138
Page 41 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133139
Page 42 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133140
Page 43 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatmentStart Da
teForm Instanc
e
 1.RADIATION TH
ERAPY 1  YES  RADIATION TREA
TMENT Feb/22/2
021 Repeating
Pages
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133141
Page 44 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Radiation Treatment
1.Category: RADIATION THERAPY
2.What is the treatment Identifier? [1]
3.Concomitant Non-drug Treatment
Pre-specified:YES
4.Treatment: [RADIATION TREATMENT]
5.Start Date: Feb/22/2021
6.Ongoing? YES
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133142
Page 45 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133143
Page 46 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133144
Page 47 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133145
Page 48 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133146
Page 49 of 146
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133147
Page 50 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133148
Page 51 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133149
Page 52 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133150
Page 53 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133151
Page 54 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133152
Page 55 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/13/2021
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133153
Page 56 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133154
Page 57 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/13/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133155
Page 58 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/13/2021
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 [BRF5GB]
5.bSample ID [BSCBGH]
5.cSample ID [BSCBGJ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133156
Page 59 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/13/2021
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 [BRF5FC]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133157
Page 60 of 146
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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/13/2021 13:03
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
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133158
Page 61 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/11/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133159
Page 62 of 146
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133160
Page 63 of 146
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133161
Page 64 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133162
Page 65 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/4/2021
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 [BRG1R4]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133163
Page 66 of 146
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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/4/2021 12:20
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
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133164
Page 67 of 146
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/4/2021
2.Erroneous Visit
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133165
Page 68 of 146
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/4/2021
3.Comments: [ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133166
Page 69 of 146
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133167
Page 70 of 146
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133168
Page 71 of 146
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133169
Page 72 of 146
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133170
Page 73 of 146
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Mar/4/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133171
Page 74 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/22/2020
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133172
Page 75 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133173
Page 76 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Timothy
Jennings Approved Mar-10-2021 20:06:42 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TimothyJennings, 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.
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133174
Page 77 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormSep-03-2020 13:54:30 (UTC-06:00) Central
Time (US & Canada)Tiffany Baum
(pfe.tbaum)Not Applicable
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133175
Page 78 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormJan-13-2021 13:14:34 (UTC-06:00) Central
Time (US & Canada)Tiffany Baum
(pfe.tbaum)Not Applicable
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133176
Page 79 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Timothy
Jennings Approved Mar-10-2021 20:06:42 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TimothyJennings, 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.
Tiffany Baum  N/A Mar-04-2021 11:38:15 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Jennings Approved Feb-21-2021 09:42:07 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TimothyJennings, 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.
Megan Felty  N/A Feb-04-2021 12:38:16 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133177
Page 80 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Timothy
Jennings Approved Jan-21-2021 16:30:16 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TimothyJennings, 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.
Tiffany Baum  N/A Jan-12-2021 13:41:26 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Jennings Approved Nov-03-2020 16:24:09 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TimothyJennings, 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.
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133178
Page 81 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-03-2020 13:53:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-03-2020 13:53:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133179
Page 82 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-03-2020 13:54:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/3/2020Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133180
Page 83 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-03-2020 13:53:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10081184Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-03-2020 13:53:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1958Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-03-2020 13:54:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-03-2020 13:54:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)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-03-2020 13:54:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
WHITEInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
FDA-CBER-2021-5683-0133181
Page 84 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-03-2020 13:54:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/3/2020Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133182
Page 85 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-03-2020 13:54:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-03-2020 13:54:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-03-2020 13:54:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133183
Page 86 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Sep-03-2020 14:05:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:High choleste
rol
Start Date: UNK/UNK/2
019
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-03-2020 14:05:53
(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-03-2020 14:05:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
High cholesterolInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-03-2020 14:05:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-03-2020 14:05:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133184
Page 87 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b
Date Location User Value Reason
Sep-03-2020 14:06:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Thimerosal all
ergy
Start Date: UNK/UNK/19
74
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-03-2020 14:06:58
(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-03-2020 14:06:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Thimerosal allergyInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-03-2020 14:06:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/1974Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-03-2020 14:06:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
1.c
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133185
Page 88 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-26-2020 14:17:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Elevated PSA
Start Date: UNK/UNK/2
019
Ongoing: YESInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133186
Page 89 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.c Line/MH Number:
Date Location User Value Reason
Oct-26-2020 14:17:01
(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
Nov-02-2020 13:00:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe madard)Query 1: Closed Response satisfies
query
Nov-02-2020 08:02:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Query 1: Answered No work up prior to
enrollment,
unknown at this
time if benign or
stable. Will update
term when Prostate
cancer is stage.
Nov-01-2020 02:21:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe madard)Query 1: Reissued:Opened GPDCLIN: Please
clarify if any work
up was done prior
to enrollment to
conclude whether
benign or stable?
please update
medical history as
applicable or else,
please further
clarify.
Oct-27-2020 15:04:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Query 1: Answered please refer to AE
Oct-27-2020 15:02:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe madard)Query 1: Opened GPDCLIN: Please
clarify the etiology
of elevated PSA
and if prostate
malignancy was
ruled out.
Oct-26-2020 14:17:01
(UTC-06:00) CentralACV0PFEINFP6000  Tiffany
BaumData Entry:
Elevated PSAInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133187
Page 90 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.tbaum)
1.c Start Date:
Date Location User Value Reason
Oct-26-2020 14:17:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-26-2020 14:17:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133188
Page 91 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Sep-03-2020 14:04:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-03-2020 14:04:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
241.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-03-2020 14:04:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-03-2020 14:04:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
66.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-03-2020 14:04:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-03-2020 14:04:03
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
38.9Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133189
Page 92 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-03-2020 14:04:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Record Identifier:: 1
Temperature: 97.7
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-03-2020 14:04:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-03-2020 14:04:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-03-2020 14:04:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-03-2020 14:04:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
FOREHEADInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133190
Page 93 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-03-2020 15:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-03-2020 15:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
251769Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133191
Page 94 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 13:55:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 13:55:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 15:36:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 13:55:09
(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-03-2020 13:55:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020 15:36:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID: BPV0LLInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133192
Page 95 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 15:36:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BPV0LLInitial Entry
5.b
Date Location User Value Reason
Sep-03-2020 15:36:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID: BPV0LMInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-03-2020 15:36:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BPV0LMInitial Entry
5.c
Date Location User Value Reason
Sep-03-2020 15:36:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID: BPV0LNInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-03-2020 15:36:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BPV0LNInitial Entry
5.d
Date Location User Value Reason
Sep-03-2020 15:36:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID: BRTY0NInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133193
Page 96 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.d Sample ID
Date Location User Value Reason
Sep-03-2020 15:36:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BRTY0NInitial Entry
5.e
Date Location User Value Reason
Sep-03-2020 15:36:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID: BRTY0PInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-03-2020 15:36:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BRTY0PInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133194
Page 97 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 13:55:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 13:55:56
(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-03-2020 15:37:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 13:55:56
(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-03-2020 13:55:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020 15:37:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID: BPTPR1Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133195
Page 98 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 15:37:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BPTPR1Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133196
Page 99 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-03-2020 15:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020 15:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-03-2020 15:37:15
(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-03-2020 15:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/3/2020 14:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020 15:37:15
(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-03-2020 15:37:15
(UTC-06:00) CentralACV0PFEINFP6000  Tiffany
BaumData Entry:
LEFTInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133197
Page 100 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.tbaum)
7. Route:
Date Location User Value Reason
Sep-03-2020 15:37:15
(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-03-2020 15:37:15
(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-03-2020 15:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133198
Page 101 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-03-2020 13:56:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133199
Page 102 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-24-2020 11:13:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/24/2020Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133200
Page 103 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Sep-24-2020 11:13:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/24/2020Initial Entry
2.a
Date Location User Value Reason
Sep-24-2020 11:13:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Record Identifier:: 1
Temperature: 97.2
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-24-2020 11:13:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-24-2020 11:13:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
97.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-24-2020 11:13:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133201
Page 104 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Sep-24-2020 11:13:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
FOREHEADInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133202
Page 105 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020 12:56:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020 12:56:58
(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-24-2020 12:57:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-24-2020 12:56:58
(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-24-2020 12:56:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
YES
Date of Collection:
Sep/24/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020 12:57:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID: BGK140Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133203
Page 106 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Sample ID
Date Location User Value Reason
Sep-24-2020 12:57:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BGK140Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133204
Page 107 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-24-2020 11:14:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-24-2020 11:14:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-24-2020 11:14:28
(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-24-2020 11:14:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/24/2020 10:57Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-24-2020 11:14:28
(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-24-2020 11:14:28
(UTC-06:00) CentralACV0PFEINFP6000  Tiffany
BaumData Entry:
LEFTInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133205
Page 108 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.tbaum)
7. Route:
Date Location User Value Reason
Sep-24-2020 11:14:28
(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-24-2020 11:14:28
(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-24-2020 11:14:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133206
Page 109 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-22-2020 15:52:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/22/2020Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133207
Page 110 of 146
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 15:30:53
(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 15:30:53
(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 15:31:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 15:30:53
(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 15:30:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020 15:31:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID: BPZBHLInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133208
Page 111 of 146
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 15:31:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BPZBHLInitial Entry
5.b
Date Location User Value Reason
Oct-22-2020 15:31:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID: BRZDFSInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020 15:31:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BRZDFSInitial Entry
5.c
Date Location User Value Reason
Oct-22-2020 15:31:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID: BRZDFTInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020 15:31:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BRZDFTInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133209
Page 112 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-22-2020 15:53:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-22-2020 15:53:55
(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 15:53:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133210
Page 113 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Oct-22-2020 15:58:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Form Created
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133211
Page 114 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Oct-22-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-22-2020 15:58:56
(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
Oct-22-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Prostate cancerInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-26-2020 14:43:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
Sep/30/2020 UNK:UNKTranscription Error
Oct-22-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-22-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
6. Toxicity Grade:
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133212
Page 115 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-22-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)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
Oct-24-2020 08:43:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 2: Closed Response satisfies
query
Oct-23-2020 07:47:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Query 2: Answered SAE was faxed same
day
Oct-23-2020 06:30:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 2: Opened SAE
RECON:Prostate
cancer(Onset
date:07Oct2020) is
not reported to
Safety database but
marked serious on
AE CRF. Confirm
seriousness and
report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Oct-23-2020 06:29:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 1: Deleted Query can be
addressed internally
Oct-22-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Prostate
cancer: Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133213
Page 116 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Event Number" is
blank.
Oct-22-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require or
prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabilit
y/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important serio
us event
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-22-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133214
Page 117 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-22-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
UnknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-22-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-22-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-09-2021 04:09:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe.madard)Query 1: Closed Response satisfies
query
Mar-08-2021 12:50:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
YESNew Information
Mar-08-2021 07:56:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Query 1: Answered waiting on records
to update, as SAE
states, records
request submitted,
they have 90 days to
fulfill request, per
subject no details at
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133215
Page 118 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
this time
Mar-07-2021 15:15:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Daria Madar
Jacobson
(pfe.madard)Query 1: Opened GPDCLIN: Please
confirm subject did
not receive any non
drug or concomitant
drug for his cancer.
If yes, please update
CRF as applicable
and send a FU SAE
report. In case a per
protocol prohibited
therapy was given,
please also update
PROHIB CM page.
Oct-22-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-22-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT RECOVERED/NOT RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-22-2020 15:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-24-2020 08:44:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020412053Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133216
Page 119 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Oct-22-2020 16:00:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Form Created
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133217
Page 120 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Oct-22-2020 16:00:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Oct-22-2020 16:00:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Oct-22-2020 16:00:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Oct-23-2020
08:52:03
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 1: C
losedDiscrepancy has
been closed.
Oct-23-2020
07:45:16
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: A
nsweredTranscription Error
Oct-23-2020
07:45:16ACV0PFEINFP6000  Tiffany Baum
(pfe.tbaum)Data Entr
y:Transcription Error
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133218
Page 121 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time
(US & Canada)Flucelvax i
nfluenza pr
ophylaxis i
ntramuscul
ar vaccine
0.5 ml onc
e
Oct-23-2020
02:41:31
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 1: O
penedClarify
FLUECELVAX
INFLUENZA
PROPHYLAXIS
INTRAMUSCULAR
VACCINE 0.5 ML
ONCE as
follows...Should the
spelling be
FLUCELVAX
INFLUENZA
PROPHYLAXIS
INTRAMUSCULAR
VACCINE 0.5 ML
ONCE? If so, update
the verbatim term as
such. Otherwise
clarify and update the
term as appropriate
or provide
reference/label.
Thank you.
Oct-22-2020
16:00:25
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Tiffany Baum
(pfe.tbaum)Data Entr
y:
Fluecelvax
influenza p
rophylaxis
intramuscu
lar vaccine
0.5 ml onc
eInitial Entry
5. Date:
Date Location User Value Reason
Oct-22-2020 16:00:25 ACV0PFEINFP6000  Tiffany Data Entry: Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133219
Page 122 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00) Central
Time (US & Canada)Baum
(pfe.tbaum)Oct/19/2020
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133220
Page 123 of 146
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Mar-08-2021 12:49:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Ann Patek
(pfe.apatek)Form Created
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133221
Page 124 of 146
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Mar-08-2021 12:49:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
RADIATION THERAPYInitial Entry
2. What is the treatment Identifier?
Date Location User Value Reason
Mar-08-2021 12:49:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Concomitant Non-drug Treatment Pre-specified:
Date Location User Value Reason
Mar-08-2021 12:49:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
YESInitial Entry
4. Treatment:
Date Location User Value Reason
Mar-08-2021 12:49:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
RADIATION TREATMENTInitial Entry
5. Start Date:
Date Location User Value Reason
Mar-08-2021 12:49:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
Feb/22/2021Initial Entry
6. Ongoing?
Date Location User Value Reason
Mar-08-2021 12:49:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ann Patek
(pfe.apatek)Data Entry:
YESInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133222
Page 125 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-12-2021 13:41:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/11/2021Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133223
Page 126 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-12-2021 13:41:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per local/national reco
mmendations and confirmed to
have received only placebo at
Vaccination 1/2Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133224
Page 127 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-13-2021 13:14:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/13/2021Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133225
Page 128 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-13-2021 13:14:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/13/2021Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133226
Page 129 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-13-2021 13:14:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/13/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-13-2021 13:14:54
(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-13-2021 13:14:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133227
Page 130 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-13-2021 15:05:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-13-2021 15:05:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-13-2021 15:05:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-13-2021 15:05:04
(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-13-2021 15:05:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
YES
Date of Collection:
Jan/13/2021Initial Entry
5.a
Date Location User Value Reason
Jan-13-2021 15:05:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
Sample ID: BRF5GBInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133228
Page 131 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Sample ID
Date Location User Value Reason
Jan-13-2021 15:05:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
BRF5GBInitial Entry
5.b
Date Location User Value Reason
Jan-13-2021 15:05:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
Sample ID: BSCBGHInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-13-2021 15:05:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
BSCBGHInitial Entry
5.c
Date Location User Value Reason
Jan-13-2021 15:05:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
Sample ID: BSCBGJInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-13-2021 15:05:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
BSCBGJInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133229
Page 132 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-13-2021 14:25:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-13-2021 14:25:08
(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-13-2021 14:25:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-13-2021 14:25:08
(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-13-2021 14:25:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
YES
Date of Collection:
Jan/13/2021Initial Entry
5.a
Date Location User Value Reason
Jan-13-2021 14:25:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
Sample ID: BRF5FCInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133230
Page 133 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Sample ID
Date Location User Value Reason
Jan-13-2021 14:25:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
BRF5FCInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133231
Page 134 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-13-2021 14:15:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-13-2021 14:15:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-13-2021 14:15:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-13-2021 14:15:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/13/2021 13:03Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-13-2021 14:15:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-13-2021 14:15:15
(UTC-06:00) CentralACV0PFEINFP6000  Tiffany
BaumData Entry:
LEFTInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133232
Page 135 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.tbaum)
7. Route:
Date Location User Value Reason
Jan-13-2021 14:15:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-13-2021 14:15:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-13-2021 14:15:15
(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-13-2021 14:15:15
(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-13-2021 14:15:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133233
Page 136 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-12-2021 13:41:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Jan/11/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-12-2021 13:41:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133234
Page 137 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-04-2021 12:57:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Feb/4/2021Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133235
Page 138 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-04-2021 12:38:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-04-2021 12:38:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-04-2021 12:39:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-04-2021 12:38:16
(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.
Feb-04-2021 12:38:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
YES
Date of Collection:
Feb/4/2021Initial Entry
5.a
Date Location User Value Reason
Feb-04-2021 12:39:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
Sample ID: BRG1R4Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133236
Page 139 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.a Sample ID
Date Location User Value Reason
Feb-04-2021 12:39:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Megan
Felty
(pfe.mfelty)Data Entry:
BRG1R4Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133237
Page 140 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-04-2021 12:57:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-04-2021 12:57:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-04-2021 12:57:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-04-2021 12:57:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Feb/4/2021 12:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-04-2021 12:57:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-04-2021 12:57:20
(UTC-06:00) CentralACV0PFEINFP6000  Tiffany
BaumData Entry:
LEFTInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133238
Page 141 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Time (US & Canada) (pfe.tbaum)
7. Route:
Date Location User Value Reason
Feb-04-2021 12:57:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-04-2021 12:57:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-04-2021 12:57:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-04-2021 12:57:20
(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
Feb-04-2021 12:57:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133239
Page 142 of 146
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021 11:38:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Mar/4/2021Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133240
Page 143 of 146
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-04-2021 11:38:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-04-2021 11:38:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
YES
Date of Contact:
Mar/4/2021Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133241
Page 144 of 146
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User ValueReason
Mar-05-2021
03:10:10
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_21
Mar-04-2021
18:15:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY
(pfe.DMW_QUERY)Query
1: Op
enedDMW7602076;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Mar-04-2021
11:39:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Tiffany Baum
(pfe.tbaum)Data
Entry
:
Mar/4
/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-04-2021 11:39:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-04-2021 11:39:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133242
Page 145 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-22-2020 15:53:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-03-2020 15:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-03-2020 13:54:58
(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 15:53:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
Sep-03-2020 15:36:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/3/2020Initial Entry
Sep-03-2020 13:54:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/3/2020Initial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133243
Page 146 of 146
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081184 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020 15:55:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Tiffany
Baum
(pfe.tbaum)Data Entry:
Click Here to EnableInitial Entry
090177e196ae3fd4\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133244