Document text
Page 1 of 363
***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: 10721064 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
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952895
Page 2 of 363
***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: 10721064 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/28/2020
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952896
Page 3 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10721064]
2.Birth Date: /1943
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:
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952897
Page 4 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952898
Page 5 of 363
***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: 10721064 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
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952899
Page 6 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952900
Page 7 of 363
***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: 10721064 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:[Hypothyroidism]
Start Date: UNK/UNK/1993
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/1995
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/1995
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Benign Prostatic Hyperplasia]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952901
Page 8 of 363
***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: 10721064 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:[Insomnia]
Start Date: UNK/UNK/2018
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Knee Pain]
Start Date: UNK/UNK/2015
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Knee Torn Meniscus]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Quadruple Coronary Artery Bypass Surgery]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952902
Page 9 of 363
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [230.0]
3.Unit: LB
4.Height: [70.0]
5.Unit: in
6.Body Mass Index: [33.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952903
Page 10 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [245252]
3.Randomization Group: [ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952904
Page 11 of 363
***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: 10721064 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/28/2020
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 [BN68C2]
5.bSample ID [BN68C3]
5.cSample ID [BN68C4]
5.dSample ID [BL9MC6]
5.eSample ID [BL9MC7]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952905
Page 12 of 363
***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: 10721064 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/28/2020
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 [BN68C1]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952906
Page 13 of 363
***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: 10721064 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/28/2020 15:33
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
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952907
Page 14 of 363
***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: 10721064 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
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952908
Page 15 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952909
Page 16 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952910
Page 17 of 363
***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: 10721064 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/16/2020
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 [BN68J4]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952911
Page 18 of 363
***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: 10721064 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/16/2020 14:07
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
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952912
Page 19 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952913
Page 20 of 363
***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: 10721064 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/21/2020
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 [BN68N5]
5.bSample ID [BNW511]
5.cSample ID [BNW512]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952914
Page 21 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952915
Page 22 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/15/2020
2.Date of First Symptom Started: Dec/9/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/26/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952916
Page 23 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Symptoms - Other
5.aSymptoms - Other Text: [nasal sinus congestion]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952917
Page 24 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Dec/14/20
20 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952918
Page 25 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/14/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ABBOTT MOLECULAR REALTIME SARS-COV-2 ASSAY
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952919
Page 26 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 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_SELF
3.Sample Collected? YES
Date of Collection:
Dec/15/2020
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 [CV18346]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952920
Page 27 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 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? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Subject completed self swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952921
Page 28 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952922
Page 29 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952923
Page 30 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952924
Page 31 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19]
Date of Diagnosis:
Dec/14/2020
3.Toxicity Grade: 1
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952925
Page 32 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952926
Page 33 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952927
Page 34 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952928
Page 35 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952929
Page 36 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952930
Page 37 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952931
Page 38 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952932
Page 39 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one Repeating
Pages
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952933
Page 40 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952934
Page 41 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952935
Page 42 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952936
Page 43 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952937
Page 44 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952938
Page 45 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952939
Page 46 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952940
Page 47 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952941
Page 48 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952942
Page 49 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952943
Page 50 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Done Not Done Not Done Repeating Pages
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952944
Page 51 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952945
Page 52 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952946
Page 53 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 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 Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done 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 Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952947
Page 54 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952948
Page 55 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952949
Page 56 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/07/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/7/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952950
Page 57 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/07/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 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:
Jan/7/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN68P9]
5.bSample ID [BNW539]
5.cSample ID [BNW53B]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952951
Page 58 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952952
Page 59 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952953
Page 60 of 363
***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: 10721064 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/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952954
Page 61 of 363
***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: 10721064 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: [ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952955
Page 62 of 363
***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: 10721064 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:
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952956
Page 63 of 363
***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: 10721064 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 [ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952957
Page 64 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instanc
e
1.ADVERSE EV
ENT 1 vertigo Aug/31/2020 UNK:
UNK NO
End Date Time:
Aug/31/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 myocardial infar
ction Mar/6/2021 UNK:U
NK NO
End Date Time:
Mar/9/2021 UNK:UNK
Repeating
Pages
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952958
Page 65 of 363
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 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)[vertigo]
4.Start Date Time: Aug/31/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/31/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT DRUG TREATMENT
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952959
Page 66 of 363
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952960
Page 67 of 363
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[myocardial infarction]
4.Start Date Time: Mar/6/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/9/2021 UNK:UNK
6.Toxicity Grade: 3
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
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952961
Page 68 of 363
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 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:
[medical history of HTN, hypercholesterolemia, CAD, CABG in 2006.]
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 WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021264461]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952962
Page 69 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952963
Page 70 of 363
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952964
Page 71 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952965
Page 72 of 363
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952966
Page 73 of 363
***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: 10721064 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. Repeating
Pages
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952967
Page 74 of 363
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952968
Page 75 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952969
Page 76 of 363
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952970
Page 77 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952971
Page 78 of 363
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952972
Page 79 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952973
Page 80 of 363
***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: 10721064 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:
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952974
Page 81 of 363
***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: 10721064 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?
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952975
Page 82 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952976
Page 83 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952977
Page 84 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952978
Page 85 of 363
***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: 10721064 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 per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952979
Page 86 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952980
Page 87 of 363
***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: 10721064 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
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952981
Page 88 of 363
***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: 10721064 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
[ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952982
Page 89 of 363
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952983
Page 90 of 363
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/19/2021
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952984
Page 91 of 363
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 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
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952985
Page 92 of 363
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Feb/19/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952986
Page 93 of 363
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10721064 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:
Feb/19/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN68PN]
5.bSample ID [BNW53Z]
5.cSample ID [BNW540]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952987
Page 94 of 363
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10721064 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:
Feb/19/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN68PP]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952988
Page 95 of 363
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/19/2021 14:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952989
Page 96 of 363
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952990
Page 97 of 363
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: 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: 10721064 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 [ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952991
Page 98 of 363
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 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?
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952992
Page 99 of 363
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952993
Page 100 of 363
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952994
Page 101 of 363
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952995
Page 102 of 363
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952996
Page 103 of 363
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952997
Page 104 of 363
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952998
Page 105 of 363
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952999
Page 106 of 363
***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: 10721064 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/21/2020
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953000
Page 107 of 363
***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: 10721064 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
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953001
Page 108 of 363
***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: 10721064 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-12-2021 08:59:56 (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.
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0953002
Page 109 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormAug-30-2020 12:36:59 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953003
Page 110 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormDec-30-2020 17:50:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953004
Page 111 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Dec-30-2020 17:50:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953005
Page 112 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Dec-30-2020 17:50:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953006
Page 113 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Dec-30-2020 17:50:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953007
Page 114 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Dec-30-2020 17:50:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953008
Page 115 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Dec-30-2020 17:50:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953009
Page 116 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6Dec-30-2020 17:50:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953010
Page 117 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormDec-31-2020 12:31:39 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953011
Page 118 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Dec-31-2020 12:31:39 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953012
Page 119 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Dec-31-2020 12:31:39 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953013
Page 120 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Dec-31-2020 12:31:39 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953014
Page 121 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Dec-31-2020 12:31:39 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953015
Page 122 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
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Time (US & Canada)Not Done
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
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Time (US & Canada)Not Done
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
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Time (US & Canada)Not Done
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
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Time (US & Canada)Not Done
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
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Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0953022
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Site No: 1072 Site Name: (1072) Optimal Research, LLC
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5.aDec-31-2020 12:32:14 (UTC-06:00) Central
Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0953023
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Site No: 1072 Site Name: (1072) Optimal Research, LLC
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5.aDec-31-2020 12:32:14 (UTC-06:00) Central
Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
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5.bDec-31-2020 12:32:14 (UTC-06:00) Central
Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
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Time (US & Canada)Not Done
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
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Time (US & Canada)Not Done
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Header Text: c4591001
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
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Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
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Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
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5.aDec-31-2020 12:32:34 (UTC-06:00) Central
Time (US & Canada)Not Done
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
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Time (US & Canada)Not Done
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
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Time (US & Canada)Not Done
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
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5.bDec-31-2020 12:32:34 (UTC-06:00) Central
Time (US & Canada)Not Done
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5.bDec-31-2020 12:32:34 (UTC-06:00) Central
Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6Dec-31-2020 12:47:29 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953113
Page 220 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormDec-31-2020 12:47:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953114
Page 221 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Dec-31-2020 12:47:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953115
Page 222 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Dec-31-2020 12:47:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953116
Page 223 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Dec-31-2020 12:47:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953117
Page 224 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Dec-31-2020 12:47:47 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953118
Page 225 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormMar-02-2021 09:50:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0953119
Page 226 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Mar-02-2021 09:50:11 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0953120
Page 227 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormMar-03-2021 09:45:23 (UTC-06:00) Central
Time (US & Canada)Not Done
FormMar-02-2021 09:50:30 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0953121
Page 228 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Mar-03-2021 09:45:23 (UTC-06:00) Central
Time (US & Canada)Not Done
1Mar-02-2021 09:50:30 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0953122
Page 229 of 363
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormFeb-19-2021 15:39:47 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0953123
Page 230 of 363
***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: 10721064 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-12-2021 08:59:56 (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-10-2021 17:44:58 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Randle
Middleton Approved Mar-04-2021 15:34:48 (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-02-2021 09:50:11 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953124
Page 231 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Randle
Middleton Approved Feb-23-2021 15:02:21 (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 Feb-19-2021 15:38:58 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Randle
Middleton Approved Jan-21-2021 16:05:44 (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 Dec-30-2020 17:43:06 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Randle
Middleton Approved Oct-28-2020 08:16:50 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953125
Page 232 of 363
***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: 10721064 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-26-2020 08:23:27 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Randle
Middleton Approved Oct-22-2020 07:37:29 (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.
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953126
Page 233 of 363
***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: 10721064 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-30-2020 12:36:14
(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-30-2020 12:36:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0953127
Page 234 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-30-2020 12:36:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/28/2020Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0953128
Page 235 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-30-2020 12:36:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10721064Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-30-2020 12:35:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1943Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-30-2020 12:36:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-30-2020 12:36:39
(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-30-2020 12:36:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0953129
Page 236 of 363
***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: 10721064 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-30-2020 12:36:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0953130
Page 237 of 363
***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: 10721064 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-30-2020 12:37:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-30-2020 12:37:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-30-2020 12:37:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0953131
Page 238 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Aug-30-2020 12:38:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:Hypothyroidi
sm
Start Date: UNK/UNK/1
993
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-30-2020 12:38:19
(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-30-2020 12:38:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypothyroidismInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-30-2020 12:38:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1993Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-30-2020 12:38:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0953132
Page 239 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Aug-30-2020 12:38:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Hypercholester
olemia
Start Date: UNK/UNK/199
5
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-30-2020 12:38:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-30-2020 12:38:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypercholesterolemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-30-2020 12:38:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-30-2020 12:38:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0953133
Page 240 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-30-2020 12:38:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History T
erm:Hypertension
Start Date: UNK/UNK/1
995
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-30-2020 12:38:45
(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-30-2020 12:38:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-30-2020 12:38:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-30-2020 12:38:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-30-2020 12:39:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0953134
Page 241 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Medical Histo
ry Term:Benign Prostatic
Hyperplasia
Start Date: UNK/UNK/2019
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Aug-30-2020 12:39:12
(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-30-2020 12:39:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Benign Prostatic HyperplasiaInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-30-2020 12:39:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-30-2020 12:39:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-30-2020 12:39:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History T
erm:Insomnia
Start Date: UNK/UNK/2
018Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0953135
Page 242 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Aug-30-2020 12:39:24
(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
Aug-30-2020 12:39:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
InsomniaInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-30-2020 12:39:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-30-2020 12:39:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-30-2020 12:39:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History T
erm:Right Knee P
ain
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0953136
Page 243 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.f Line/MH Number:
Date Location User Value Reason
Aug-30-2020 12:39:46
(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
Aug-30-2020 12:39:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Right Knee PainInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-30-2020 12:39:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-30-2020 12:39:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-30-2020 12:41:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histor
y Term:Right Knee Torn
Meniscus
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/20
15Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0953137
Page 244 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.g Line/MH Number:
Date Location User Value Reason
Aug-30-2020 12:41:23
(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
Aug-30-2020 12:41:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Right Knee Torn MeniscusInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-30-2020 12:41:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-30-2020 12:41:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.h
Date Location User Value Reason
Aug-30-2020 12:41:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical Hi
story Term
:Quadruple Coronary
Artery Bypass Surger
y
Start Date: UNK/UNK/2006Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0953138
Page 245 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: NO
End Date:
UNK/UNK/2006
1.h Line/MH Number:
Date Location User Value Reason
Aug-30-2020 12:41:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-30-2020 12:41:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Quadruple Coronary Artery Bypass
SurgeryInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-30-2020 12:41:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2006Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-30-2020 12:41:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2006Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0953139
Page 246 of 363
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Aug-30-2020 12:37:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-30-2020 12:37:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
230.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-30-2020 12:37:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-30-2020 12:37:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
70.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-30-2020 12:37:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-30-2020 12:37:49
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
33.0Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0953140
Page 247 of 363
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-30-2020 12:37:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.8
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-30-2020 12:37:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-30-2020 12:37:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-30-2020 12:37:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-30-2020 12:37:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0953141
Page 248 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-30-2020 12:43:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-30-2020 12:43:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
245252Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0953142
Page 249 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-30-2020 12:43:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-30-2020 12:43:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-30-2020 13:00:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-30-2020 12:43:23
(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-30-2020 12:43:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-30-2020 13:00:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN68C2Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0953143
Page 250 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Aug-30-2020 13:00:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN68C2Initial Entry
5.b
Date Location User Value Reason
Aug-30-2020 13:00:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN68C3Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-30-2020 13:00:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN68C3Initial Entry
5.c
Date Location User Value Reason
Aug-30-2020 13:00:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN68C4Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-30-2020 13:00:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN68C4Initial Entry
5.d
Date Location User Value Reason
Aug-30-2020 13:01:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9MC6Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0953144
Page 251 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.d Sample ID
Date Location User Value Reason
Aug-30-2020 13:01:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BL9MC6Initial Entry
5.e
Date Location User Value Reason
Aug-30-2020 13:01:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BL9MC7Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-30-2020 13:01:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BL9MC7Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0953145
Page 252 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-30-2020 12:43:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-30-2020 12:43:32
(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-30-2020 13:00:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-30-2020 12:43:32
(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-30-2020 12:43:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-30-2020 13:00:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN68C1Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0953146
Page 253 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Aug-30-2020 13:00:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN68C1Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0953147
Page 254 of 363
***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: 10721064 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-30-2020 12:44:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-30-2020 12:44:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-30-2020 12:44:09
(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-30-2020 12:44:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 15:33Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-30-2020 12:44:09
(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-30-2020 12:44:09
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0953148
Page 255 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-30-2020 12:44:09
(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-30-2020 12:44:09
(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-30-2020 12:44:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0953149
Page 256 of 363
***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: 10721064 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-30-2020 12:44:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0953150
Page 257 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-16-2020 14:43:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953151
Page 258 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-16-2020 14:44:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Sep-16-2020 14:44:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 97.3
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-16-2020 14:44:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-16-2020 14:44:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-16-2020 14:44:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (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-2021-5683-0953152
Page 259 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.a Temperature Location:
Date Location User Value Reason
Sep-16-2020 14:44:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953153
Page 260 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 16:01:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 16:01:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-16-2020 16:01:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-16-2020 16:01:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-16-2020 16:01:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020 16:01:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN68J4Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953154
Page 261 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Sep-16-2020 16:01:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN68J4Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953155
Page 262 of 363
***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: 10721064 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
Sep-16-2020 14:45:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-16-2020 14:45:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-16-2020 14:45:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-16-2020 14:45:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/16/2020 14:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-16-2020 14:45:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-16-2020 14:45:06
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953156
Page 263 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-16-2020 14:45:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-16-2020 14:45:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-16-2020 14:45:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953157
Page 264 of 363
***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: 10721064 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-26-2020 14:22:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-26-2020 08:23:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Oct-24-2020 11:00:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened As per CRF
guidelines, the
treatment period is
defined as 1st
vaccination visit
through the
1-month post
vaccination visit
after the 2nd
vaccination. Hence,
please complete
treatment
disposition CRF
and update date of
EOT to match the
date the Visit 3.
Oct-21-2020 14:59:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/21/2020Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0953158
Page 265 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-21-2020 14:59:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-24-2020 09:37:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Balaji
Prabu RQuery 1: Closed Query raised in
hidden items
Oct-24-2020 07:28:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened As per CRF
guidelines, the
treatment period is
defined as 1st
vaccination visit
through the 1-month
post vaccination
visit after the 2nd
vaccination. Hence,
please complete
treatment disposition
CRF and update date
of EOT to match the
date the Visit 3.
Oct-21-2020 14:59:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 14:59:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-21-2020 14:59:14
(UTC-06:00) CentralACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0953159
Page 266 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada) barcodes are
entered. Please
review and correct
as appropriate.
Oct-21-2020 14:59:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/21/2020Initial Entry
5.a
Date Location User Value Reason
Oct-21-2020 14:59:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN68N5Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020 14:59:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN68N5Initial Entry
5.b
Date Location User Value Reason
Oct-21-2020 14:59:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNW511Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020 14:59:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNW511Initial Entry
5.c
Date Location User Value Reason
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0953160
Page 267 of 363
***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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-21-2020 14:59:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNW512Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020 14:59:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNW512Initial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0953161
Page 268 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-04-2021 00:11:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Closed as data
entered.
Dec-31-2020 12:55:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Changed data per
query
Dec-31-2020 03:44:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened DM: Kindly
consider to update
missing COVID
TEST form or else
clarify. Thank you.
Dec-30-2020 17:48:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-30-2020 17:47:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Dec-30-2020 17:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Dec-30-2020 17:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0953162
Page 269 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/2020Form: DATE OF VISIT - ILLNESS ONSET - 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: 10721064 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Dec-30-2020 17:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/15/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-30-2020 17:43:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae4044\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0953163
Page 270 of 363
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/15/202
…[truncated]