125742 S1 M5 CRF c4591001 1072 10721007

Document text

Page 1 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952238
Page 2 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/17/2020
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952239
Page 3 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10721007]
2.Birth Date: /1949
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:
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952240
Page 4 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/17/2020
2.Erroneous Visit
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952241
Page 5 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952242
Page 6 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952243
Page 7 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/2013
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2013
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis]
Start Date: UNK/UNK/2005
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Heartburn]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952244
Page 8 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Carotid Artery Disease]
Start Date: UNK/UNK/2013
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hodgkin's Lymphoma]
Start Date: Jun/UNK/2016
Ongoing: NO
End Date:
Jun/UNK/2016
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Non-Hodgkins's Lymphoma]
Start Date: Jun/UNK/2016
Ongoing: NO
End Date:
Jun/UNK/2016
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952245
Page 9 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Aug/17/2020
2.Weight: [180.0]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [30.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952246
Page 10 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/17/2020
2.Randomization Number: [231132]
3.Randomization Group: [ ]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952247
Page 11 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/17/2020
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 [BN683G]
5.bSample ID [BN683H]
5.cSample ID [BN683J]
5.dSample ID [BL9M7D]
5.eSample ID [BL9M7F]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952248
Page 12 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/17/2020
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 [BN683F]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952249
Page 13 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/17/2020 17:35
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
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952250
Page 14 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952251
Page 15 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952252
Page 16 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952253
Page 17 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN68K1]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952254
Page 18 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/23/2020 16:38
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
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952255
Page 19 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952256
Page 20 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [BN68NB]
5.bSample ID [BNW51C]
5.cSample ID [BNW51D]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952257
Page 21 of 179
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952258
Page 22 of 179
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952259
Page 23 of 179
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952260
Page 24 of 179
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952261
Page 25 of 179
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952262
Page 26 of 179
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952263
Page 27 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952264
Page 28 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: [ ]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952265
Page 29 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952266
Page 30 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952267
Page 31 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952268
Page 32 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952269
Page 33 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952270
Page 34 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952271
Page 35 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952272
Page 36 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952273
Page 37 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: [ ]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952274
Page 38 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952275
Page 39 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952276
Page 40 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952277
Page 41 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Transient Ischaemic
Attack Sep/4/2020 UNK:
UNK NO
End Date Time:
Sep/9/2020 UNK:UNK
 Repeating
Pages
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952278
Page 42 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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)[Transient Ischaemic Attack]
4.Start Date Time: Sep/4/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/9/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952279
Page 43 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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:
[carotid artery disease]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020367085]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952280
Page 44 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryMedication E
rrorStart DateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
 1.Not Applica
ble Not Applicabl
e Not Applica
ble Not Applicable  Not Applicable  Repeating
Pages
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952281
Page 45 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of
Medication Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still
ongoing?Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication
given?Not Applicable Comments
7.Was a Non-Drug Treatment given? Not Applicable Comments
8.Did the Medication Error cause the
subject to be discontinued from the
study?Not Applicable Comments
9.Was this medication error
associated with any adverse events?Not Applicable Comments
10.Serious Adverse Event Number: For
Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952282
Page 46 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952283
Page 47 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952284
Page 48 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applica
ble Repeating
Pages
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952285
Page 49 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952286
Page 50 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryTreatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Start Date Form Instance
 1.Not Applicab
le Not Applicable  Not Applicable  Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952287
Page 51 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1.Category: Not Applicable Comments
2.What is the treatment Identifier? Not Applicable
[ ]Comments
3.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952288
Page 52 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
 1.Not Applicable  Not Applicable  Repeating Pages
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952289
Page 53 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952290
Page 54 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952291
Page 55 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952292
Page 56 of 179
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952293
Page 57 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952294
Page 58 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952295
Page 59 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952296
Page 60 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952297
Page 61 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952298
Page 62 of 179
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952299
Page 63 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952300
Page 64 of 179
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952301
Page 65 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/23/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952302
Page 66 of 179
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952303
Page 67 of 179
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Done
//Comments
Cause of Death
2.Cause of Death Status: Not Done
Cause of Death: Not Done
[ ]
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952304
Page 68 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/22/2020
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952305
Page 69 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952306
Page 70 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Randle
Middleton Approved Mar-04-2021 10:21:48 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RandleMiddleton, 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.
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952307
Page 71 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormAug-18-2020 07:27:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0952308
Page 72 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-23-2020 14:04:09 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952309
Page 73 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Sep-23-2020 14:04:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952310
Page 74 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Sep-23-2020 14:04:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952311
Page 75 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Sep-23-2020 14:04:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952312
Page 76 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Sep-23-2020 14:04:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952313
Page 77 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Sep-23-2020 14:04:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952314
Page 78 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6Sep-23-2020 14:04:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952315
Page 79 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
7Sep-23-2020 14:04:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952316
Page 80 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
8Sep-23-2020 14:04:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952317
Page 81 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
9Sep-23-2020 14:04:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952318
Page 82 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
10Sep-23-2020 14:04:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952319
Page 83 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-23-2020 14:04:51 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952320
Page 84 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Sep-23-2020 14:04:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952321
Page 85 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Sep-23-2020 14:04:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952322
Page 86 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Sep-23-2020 14:04:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952323
Page 87 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Sep-23-2020 14:04:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952324
Page 88 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Sep-23-2020 14:04:51 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952325
Page 89 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-23-2020 14:05:07 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952326
Page 90 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Sep-23-2020 14:05:07 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952327
Page 91 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Sep-23-2020 14:05:07 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952328
Page 92 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Sep-23-2020 14:05:07 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952329
Page 93 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Sep-23-2020 14:05:07 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952330
Page 94 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Sep-23-2020 14:05:07 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952331
Page 95 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6Sep-23-2020 14:05:07 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952332
Page 96 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
7Sep-23-2020 14:05:07 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952333
Page 97 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
8Sep-23-2020 14:05:07 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952334
Page 98 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
9Sep-23-2020 14:05:07 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952335
Page 99 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
10Sep-23-2020 14:05:07 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952336
Page 100 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-23-2020 14:05:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952337
Page 101 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Sep-23-2020 14:05:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952338
Page 102 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Sep-23-2020 14:05:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952339
Page 103 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Sep-23-2020 14:05:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952340
Page 104 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Sep-23-2020 14:05:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952341
Page 105 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Sep-23-2020 14:05:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952342
Page 106 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6Sep-23-2020 14:05:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952343
Page 107 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-23-2020 14:05:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952344
Page 108 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Sep-23-2020 14:05:43 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952345
Page 109 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Sep-23-2020 14:05:43 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952346
Page 110 of 179
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormMar-03-2021 10:47:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952347
Page 111 of 179
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Mar-03-2021 10:47:53 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952348
Page 112 of 179
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormMar-03-2021 10:48:12 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952349
Page 113 of 179
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Mar-03-2021 10:48:12 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952350
Page 114 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Randle
Middleton Approved Mar-04-2021 10:21:48 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RandleMiddleton, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-03-2021 10:46:47 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Randle
Middleton Approved Oct-28-2020 08:12:54 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RandleMiddleton, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-27-2020 17:10:19 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Randle
Middleton Approved Oct-26-2020 08:04:36 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952351
Page 115 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Affidavit:
By my dated signature below, I, RandleMiddleton, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-22-2020 16:03:29 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Randle
Middleton Approved Oct-22-2020 06:50:38 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RandleMiddleton, 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.
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952352
Page 116 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-18-2020 07:26:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-18-2020 07:26:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952353
Page 117 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-18-2020 07:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/17/2020Initial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952354
Page 118 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-02-2020 06:55:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Oct-01-2020 10:40:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered The AE has been entered in
CRF.
Sep-23-2020 04:29:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020367085
mild transient eschemic
attack(onset date:
04Sep2020)was reported as
serious in Safety database
but missing in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Aug-18-2020 07:26:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10721007Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-18-2020 07:26:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1949Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-18-2020 07:27:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952355
Page 119 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-18-2020 07:27:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-18-2020 07:27:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952356
Page 120 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-18-2020 07:27:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952357
Page 121 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-18-2020 07:27:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-18-2020 07:27:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-18-2020 07:27:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952358
Page 122 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Aug-18-2020 07:40:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Hypercholester
olemia
Start Date: UNK/UNK/201
3
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-18-2020 07:40:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 07:40:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypercholesterolemiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-18-2020 07:40:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-18-2020 07:40:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952359
Page 123 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b
Date Location User Value Reason
Aug-18-2020 07:40:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History T
erm:Hypertension
Start Date: UNK/UNK/2
013
Ongoing: YESInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952360
Page 124 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b Line/MH Number:
Date Location User Value Reason
Aug-18-2020 07:40:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-01-2020 16:22:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-01-2020 09:45:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered medical history
updated
Sep-29-2020 07:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened On review of the
SAE report for TIA,
prior events of
Hodgkins lymphoma
and non-Hodgkins
lymphoma (with
treatment) have been
mentioned, yet do
not appear in the
CRF. Please review
for clinical
relevance and
update Med Hx as
appropriate.
Aug-18-2020 07:40:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-18-2020 07:40:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.b Ongoing:
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952361
Page 125 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Aug-18-2020 07:40:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-18-2020 07:40:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History T
erm:Osteoarthritis
Start Date: UNK/UNK/2
005
Ongoing: YESInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952362
Page 126 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.c Line/MH Number:
Date Location User Value Reason
Aug-18-2020 07:40:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 07:40:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OsteoarthritisInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-18-2020 07:40:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-18-2020 07:40:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-18-2020 07:41:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History T
erm:Heartburn
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952363
Page 127 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.d Line/MH Number:
Date Location User Value Reason
Aug-18-2020 07:41:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 07:41:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HeartburnInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-18-2020 07:41:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-18-2020 07:41:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-01-2020 09:44:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:Carotid Artery
Disease
Start Date: UNK/UNK/201
3
Ongoing: YESInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952364
Page 128 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.e Line/MH Number:
Date Location User Value Reason
Oct-01-2020 09:44:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-01-2020 09:44:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Carotid Artery DiseaseInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-01-2020 09:44:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-01-2020 09:44:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-01-2020 09:56:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numb
er:6
Medical History
Term:Hodgkin's Lymp
homa
Start Date: Jun/UNK/2016
Ongoing: NO
End Date:
Jun/UNK/20
16Transcription Error
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952365
Page 129 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-01-2020 09:56:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical History
Term:hodgkin's lymp
homa
Start Date: Jun/UNK/2016
Ongoing: NO
End Date:
Jun/UNK/20
16Initial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952366
Page 130 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.f Line/MH Number:
Date Location User Value Reason
Oct-01-2020 09:56:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-01-2020 09:56:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Hodgkin's LymphomaTranscription Error
Oct-01-2020 09:56:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
hodgkin's lymphomaInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-01-2020 09:56:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/UNK/2016Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-01-2020 09:56:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jun/UNK/2016Initial Entry
1.g
Date Location User Value Reason
Oct-01-2020 09:58:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histo
ry Term:Non-Hodgkins's L
ymphoma
Start Date: Jun/UNK/2016Initial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952367
Page 131 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: NO
End Date:
Jun/UNK/2016
1.g Line/MH Number:
Date Location User Value Reason
Oct-01-2020 09:58:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-01-2020 09:58:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Non-Hodgkins's LymphomaInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-01-2020 09:58:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/UNK/2016Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-01-2020 09:58:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jun/UNK/2016Initial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952368
Page 132 of 179
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Aug-18-2020 07:32:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-18-2020 07:32:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
180.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-18-2020 07:32:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-18-2020 07:32:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
64.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-18-2020 07:32:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-18-2020 07:32:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.9Initial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952369
Page 133 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7.a
Date Location User Value Reason
Aug-18-2020 07:32:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.9
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-18-2020 07:32:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-18-2020 07:32:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-18-2020 07:32:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-18-2020 07:32:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952370
Page 134 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-18-2020 07:38:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-18-2020 07:38:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
231132Initial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952371
Page 135 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-18-2020 07:38:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-18-2020 07:38:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020 07:15:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-20-2020 04:23:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-18-2020 07:38:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-18-2020 07:38:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952372
Page 136 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Aug-21-2020 07:33:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Katherine Liau Query 1: Closed Response satisfies
query
Aug-21-2020 07:18:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Aug-20-2020 04:36:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Katherine Liau Query 1: Opened Please use barcode
pen to provide 5
expected sample IDs
for immunogenicity
aliquots; else provide
reason in Q4 as to
why sample was not
collected.
5.a
Date Location User Value Reason
Aug-21-2020 07:15:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN683GInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-21-2020 07:15:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN683GInitial Entry
5.b
Date Location User Value Reason
Aug-21-2020 07:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN683HInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952373
Page 137 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.b Sample ID
Date Location User Value Reason
Aug-21-2020 07:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN683HInitial Entry
5.c
Date Location User Value Reason
Aug-21-2020 07:16:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN683JInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-21-2020 07:16:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN683JInitial Entry
5.d
Date Location User Value Reason
Aug-21-2020 07:16:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9M7DInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-21-2020 07:16:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BL9M7DInitial Entry
5.e
Date Location User Value Reason
Aug-21-2020 07:16:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9M7FInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952374
Page 138 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.e Sample ID
Date Location User Value Reason
Aug-21-2020 07:16:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BL9M7FInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952375
Page 139 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-18-2020 07:38:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-18-2020 07:38:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020 07:14:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-20-2020 04:23:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-18-2020 07:38:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-18-2020 07:38:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952376
Page 140 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Aug-21-2020 07:14:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN683FInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-21-2020 07:14:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN683FInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952377
Page 141 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-18-2020 07:39:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-18-2020 07:39:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-18-2020 07:39:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-18-2020 07:39:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020 17:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-18-2020 07:39:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-18-2020 07:39:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952378
Page 142 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Route:
Date Location User Value Reason
Aug-18-2020 07:39:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-18-2020 07:39:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-18-2020 07:39:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952379
Page 143 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-18-2020 07:39:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952380
Page 144 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-08-2020 06:31:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-07-2020 15:37:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Original value is
correct
Oct-06-2020 09:39:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened PDQ: DOV at this
visit is out of
window (14 day)
from DOV (17/Aug
/2020) at
V1D1VX1L. Please
either update DOV
or confirm whether
visit is out of
window due to
temporary delay of
vaccination/ else
provide details as
appropriate.
Oct-02-2020 02:07:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-01-2020 09:19:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Oct-01-2020 09:19:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
Sep-25-2020 01:51:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly review
and complete ‘Date
of Visit, Nasal
Swab, Vaccination,
Vital Signs' forms at
this visit. Thank
you.
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952381
Page 145 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Oct-01-2020 09:20:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
2.a
Date Location User Value Reason
Oct-01-2020 09:20:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.1
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-01-2020 09:20:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-01-2020 09:20:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.1Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-01-2020 09:20:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952382
Page 146 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-01-2020 09:20:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952383
Page 147 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020 09:20:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020 09:20:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020 09:21:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-01-2020 09:20:26
(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-01-2020 09:20:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020 09:21:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN68K1Initial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952384
Page 148 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Oct-01-2020 09:21:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN68K1Initial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952385
Page 149 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-01-2020 09:22:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-01-2020 09:22:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-01-2020 09:22:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-01-2020 09:22:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020 16:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-01-2020 09:22:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-01-2020 09:22:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952386
Page 150 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Route:
Date Location User Value Reason
Oct-01-2020 09:22:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-01-2020 09:22:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-01-2020 09:22:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952387
Page 151 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-24-2020 02:57:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-23-2020 15:08:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Oct-23-2020 03:19:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Patient
completed the
treatment phase and
reached at Visit 3.
Kindly consider to
update EOT form
with matching V3
date or else clarify.
Thank you.
Oct-22-2020 16:03:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952388
Page 152 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 16:03:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 16:03:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 16:04:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 16:03:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-22-2020 16:03:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
Oct-22-2020 16:04:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN68NBInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952389
Page 153 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 16:04:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN68NBInitial Entry
5.b
Date Location User Value Reason
Oct-22-2020 16:05:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW51CTranscription Error
Oct-22-2020 16:04:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW51DInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020 16:05:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNW51CTranscription Error
Oct-22-2020 16:04:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNW51DInitial Entry
5.c
Date Location User Value Reason
Oct-22-2020 16:04:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW51DInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020 16:04:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNW51DInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952390
Page 154 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-23-2020 15:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-23-2020 15:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-23-2020 15:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952391
Page 155 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Sep-23-2020 14:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952392
Page 156 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 14:03:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-23-2020 14:03:24
(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-25-2020
16:55:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 2: Close
dResponse
satisfies query
Oct-21-2020
16:54:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answ
eredThe site will
provide test
result
information
provided by the
subject and will
submit a follow
up SAE report.
Oct-19-2020
01:19:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 2: Opene
dClin: Please
confirm if any
SARS-CoV-2
(NAAT or
other) tests
were
performed.
Please provide
any test results
and update
accordingly the
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952393
Page 157 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
initial SAE
report via an
SAE follow-up
report.
Oct-18-2020
15:14:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 2: Candi
dateClin: Please
confirm if any
SARS-CoV-2
(NAAT or
other) tests
were
performed.
Please provide
any test results
and update
accordingly the
initial SAE
report via an
SAE follow-up
report.
Oct-01-2020
10:59:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Close
dDiscrepancy
has been closed.
Oct-01-2020
09:30:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answ
eredChanged
Information
Oct-01-2020
09:30:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Transient Ischa
emic AttackChanged
Information
Sep-23-2020
17:43:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Opene
dSpacing:
Verbatim Term
contains
leading, trailing
or more than
one consecutive
space.
Sep-23-2020
14:03:24ACV0PFEINFP6000  Data Entry:
Mild Transient IInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952394
Page 158 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-06:00)
Central Time (US
& Canada)schaemic Attac
k
4. Start Date Time:
Date Location User Value Reason
Sep-23-2020 14:03:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-23-2020 14:03:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/9/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-23-2020 14:03:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-24-2020 03:35:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 14:03:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Mild
Transient Ischaemic
Attack: Response to
"Is the adverse event
serious?" is 'Yes' but
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952395
Page 159 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
"Serious Adverse
Event Number" is
blank.
Sep-23-2020 14:03:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated wi
th congenital anomaly or birth de
fect?
NO
Did this serious event result in de
ath?
NO
Did this serious event require or p
rolong hospitalization?
YES
Did this serious event result in pe
rsistent or significant disability/in
capacity?
NO
Is this serious event life threateni
ng?
NO
Other medically important seriou
s 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
Sep-23-2020 14:03:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952396
Page 160 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-09-2020
04:37:05
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query 1: Cl
osedResponse
satisfies query
Oct-07-2020
15:37:35
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query 1: A
nsweredOriginal value
is correct
Oct-03-2020
04:27:29
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query 1: R
eissued:Op
enedDM: Please
review "If not
related to study
treatment
other" field,
following text
was indicated
in the comment
field [carotid
artery disease].
Any
symptoms,
AEs or other
key data
should be
collected on
the appropriate
page. Else
clarify in query
response.
Oct-01-2020
09:42:11
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query 1: A
nsweredChanged data
per query
Sep-24-2020
13:46:29
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: O
penedPlease review
"If not related
to study
treatment
other" field,
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0952397
Page 161 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Canada) the following
text was
indicated in the
comment field
[carotid artery
disease]. Any
symptoms,
AEs or other
key data
should be
collected on
the appropriate
page. If this is
already in the
predefined list
above please
choose the
appropriate
value. Please
review and
update as
necessary.
Sep-23-2020
14:03:24
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
NOT REL
ATED
If Not Rel
ated to stu
dy treatm
ent(s), thi
s event is
due to:
OTHER
If Othe
r, speci
fy:
caroti
d arte
ry dis
easeInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0952398
Page 162 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-23-2020 14:03:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020 14:03:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-23-2020 14:03:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-02-2020 06:58:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Oct-01-2020 09:59:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-01-2020 09:59:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Oct-01-2020 04:44:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020367085
for reported event outcome
was updated to
Recovered/Resolved in
SAE form however,reported
as
RECOVERED/RESOLVED
WITH SEQUELAE on AE
CRF.Please confirm correct
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0952399
Page 163 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
outcome.If safety update is
required,please submit a
follow up AEM form
Sep-23-2020 14:03:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVED
WITH SEQUELAEInitial Entry
14.Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-23-2020 14:03:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15.Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-24-2020 03:35:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020367085Initial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952400
Page 164 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 14:04:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Medication Error (Type of Medication Error):
Date Location User Value Reason
Sep-23-2020 14:04:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Start Date:
Date Location User Value Reason
Sep-23-2020 14:04:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Is the medication error still ongoing?
Date Location User Value Reason
Sep-23-2020 14:04:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-23-2020 14:04:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020 14:04:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952401
Page 165 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-23-2020 14:04:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
8. Did the Medication Error cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-23-2020 14:04:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Was this medication error associated with any adverse events?
Date Location User Value Reason
Sep-23-2020 14:04:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
10. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-23-2020 14:04:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952402
Page 166 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Sep-23-2020 14:04:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Category:
Date Location User Value Reason
Sep-23-2020 14:04:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Sep-23-2020 14:04:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial 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
Sep-23-2020 14:04:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Date:
Date Location User Value Reason
Sep-23-2020 14:04:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952403
Page 167 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Sep-23-2020 14:05:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Category:
Date Location User Value Reason
Sep-23-2020 14:05:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Sep-23-2020 14:05:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial 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
Sep-23-2020 14:05:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Dose:
Date Location User Value Reason
Sep-23-2020 14:05:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Dose Unit:
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952404
Page 168 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-23-2020 14:05:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
7. Dose Frequency:
Date Location User Value Reason
Sep-23-2020 14:05:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
8. Route:
Date Location User Value Reason
Sep-23-2020 14:05:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
9. Start Date:
Date Location User Value Reason
Sep-23-2020 14:05:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
10. Ongoing?
Date Location User Value Reason
Sep-23-2020 14:05:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952405
Page 169 of 179
***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, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 14:05:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. What is the treatment Identifier?
Date Location User Value Reason
Sep-23-2020 14:05:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Concomitant Non-drug Treatment Pre-specified:
Date Location User Value Reason
Sep-23-2020 14:05:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Treatment:
Date Location User Value Reason
Sep-23-2020 14:05:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Start Date:
Date Location User Value Reason
Sep-23-2020 14:05:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Ongoing?
Date Location User Value Reason
Sep-23-2020 14:05:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952406
Page 170 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Transfusion Type:
Date Location User Value Reason
Sep-23-2020 14:05:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Date of Transfusion:
Date Location User Value Reason
Sep-23-2020 14:05:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952407
Page 171 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-03-2021 10:46:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/23/2021Initial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952408
Page 172 of 179
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-04-2021 08:14:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for V
accination 3
Participant is:
eligible and NOT confirmed to
have received only placebo at V
accination 1/2Transcription Error
Mar-03-2021 10:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is NOT willing to return
for Vaccination 3 OR otherwise not
eligibleInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952409
Page 173 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-03-2021 10:47:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/23/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Mar-04-2021
16:18:41
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_35
Mar-04-2021
08:14:41
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dChanged data per query
Mar-03-2021
16:51:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7587819;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Mar-03-2021
10:47:12
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000  Data
Entry
:
ASSE
SS ELInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0952410
Page 174 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Canada) IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ON
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952411
Page 175 of 179
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Mar-03-2021 10:47:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952412
Page 176 of 179
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Mar-03-2021 10:48:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952413
Page 177 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-23-2020 15:08:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-18-2020 07:38:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-18-2020 07:27:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-11-2020 14:48:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-09-2020 13:40:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Per source subject
reported both on
17/AUG/2020. Had
a pet scan done in
July and was normal
and he has a pet scan
every six months
Dec-07-2020 15:54:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL Please
confirm subject's
past med history of
both Hodgkin's
lymphoma and
non-Hodgkin's
lymphoma, both
occurring in 2016
Oct-23-2020 15:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
Aug-18-2020 07:38:20
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/17/2020Initial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952414
Page 178 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
Aug-18-2020 07:27:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/17/2020Initial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952415
Page 179 of 179
***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: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-28-2020 12:07:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-27-2020 17:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
Oct-27-2020 17:10:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Oct-27-2020 17:10:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Changed
Information
Oct-25-2020 07:41:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Kindly provide
sign. Thank you.
Oct-23-2020 15:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Oct-23-2020 15:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
Oct-23-2020 03:20:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Please enable
signature form and
provide sign. Thank
you.
Oct-21-2020 18:27:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Oct-21-2020 18:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae4043\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952416