125742 S1 M5 CRF c4591001 1072 10721037

Document text

Page 1 of 478
***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: 10721037 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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952417
Page 2 of 478
***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: 10721037 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/24/2020
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952418
Page 3 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10721037]
2.Birth Date: 1949
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952419
Page 4 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952420
Page 5 of 478
***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: 10721037 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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952421
Page 6 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952422
Page 7 of 478
***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: 10721037 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:[Mild Hypertension]
Start Date: UNK/UNK/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/2005
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Brain Arteriovenous Malformation]
Start Date: UNK/UNK/2008
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Uterine Ablation]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/2004
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952423
Page 8 of 478
***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: 10721037 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:[Bilateral tubal ligation]
Start Date: UNK/UNK/1983
Ongoing: NO
End Date:
UNK/UNK/1983
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Menorrhagia]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/2004
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952424
Page 9 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
2.Weight: [168.0]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [28.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952425
Page 10 of 478
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/24/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952426
Page 11 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/24/2020
2.Randomization Number: [237336]
3.Randomization Group: [ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952427
Page 12 of 478
***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: 10721037 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/24/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN687G]
5.bSample ID [BN687H]
5.cSample ID [BN687J]
5.dSample ID [BL9M9D]
5.eSample ID [BL9M9F]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952428
Page 13 of 478
***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: 10721037 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/24/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN687F]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952429
Page 14 of 478
***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: 10721037 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/24/2020 13:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952430
Page 15 of 478
***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: 10721037 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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952431
Page 16 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952432
Page 17 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Oct/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952433
Page 18 of 478
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/7/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952434
Page 19 of 478
***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: 10721037 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:
Oct/7/2020
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 [BN68KY]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952435
Page 20 of 478
***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: 10721037 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?YES
Date of First Delay:
Sep/9/2020
Reason(s) for Temporary Delay of Vaccination
RECENT NON-STUDY VACCINATION
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/7/2020 12:34
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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952436
Page 21 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952437
Page 22 of 478
***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: 10721037 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:
Nov/6/2020
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 [BNW52P]
5.bSample ID [BNW52R]
5.cSample ID [BN68P0]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952438
Page 23 of 478
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/21/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952439
Page 24 of 478
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/21/2020
2.Date of First Symptom Started: Dec/18/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/2/2021
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? YES
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? YES
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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952440
Page 25 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Symptoms - Other
5.aSymptoms - Other Text: [fatigue]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952441
Page 26 of 478
***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: 10721037 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/27/20
20 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952442
Page 27 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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/27/2020
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: [ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952443
Page 28 of 478
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 10721037 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/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 [CV18311]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952444
Page 29 of 478
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: 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: 10721037 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:[self swab collected by subject]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952445
Page 30 of 478
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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: YES
Number of Visits or Contacts:
[1]
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?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952446
Page 31 of 478
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Dec/27/2020  YES  Repeating Pages
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952447
Page 32 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Dec/27/2020
4.Ongoing? YES
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952448
Page 33 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Treatment I
dentifierCon Non-Drug Treatme
nts Pre-specifiedTreatment TreatmentStart D
ateForm Instan
ce
 1.1  YES  HIGH FLOW OXYGE
N THERAPY HIGH FLOW OXYGE
N THERAPY Dec/27/
2020 Repeating
Pages
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952449
Page 34 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1]
2.Concomitant Non-drug Treatment
Pre-specified:YES
3.Treatment: HIGH FLOW OXYGEN THERAPY
4.Treatment: [HIGH FLOW OXYGEN THERAPY]
5.Start Date: Dec/27/2020
6.Ongoing? YES
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952450
Page 35 of 478
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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 pneumonia]
Date of Diagnosis:
Dec/27/2020
3.Toxicity Grade: 3
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952451
Page 36 of 478
***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: 10721037 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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952452
Page 37 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952453
Page 38 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for La
b TestVendor NameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.CLINICAL CHE
MISTRY Huntsville Hosp
ital Lab Dec/27/202
0 BLOOD Sponsor-Defined
IdentifierTest:Resu
lt:
329  Not D
one 5.4 
30  Not D
one 29 
28  Not D
one 36 
35  Not D
one 134 
21  Not D
one 0.3 
47  Not D
one 16 
48  Not D
one 0.9 Repeating
Pages
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952454
Page 39 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY Comments
2.Laboratory Name and Address [Huntsville Hospital Lab] Comments
3.Collection Date: Dec/27/2020 Comments
4.Specimen Type: BLOOD Comments
Lab Result
5.aSponsor ID: [329] Comments
Test: C Reactive Protein_PX329
Result: [5.4] Comments
Not Done: Comments
LNMT Low
[3]
High
[10]
Unit
mg/dLComments
5.bSponsor ID: [30] Comments
Test: Alanine Aminotransferase_PX30
Result: [29] Comments
Not Done: Comments
LNMT Low
[7]
High
[56]
Unit
U/LComments
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952455
Page 40 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.cSponsor ID: [28] Comments
Test: Aspartate Aminotransferase_PX28
Result: [36] Comments
Not Done: Comments
LNMT Low
[5]
High
[40]
Unit
U/LComments
5.dSponsor ID: [35] Comments
Test: Alkaline Phosphatase_PX35
Result: [134] Comments
Not Done: Comments
LNMT Low
[53]
High
[141]
Unit
U/LComments
5.eSponsor ID: [21] Comments
Test: Bilirubin_PX21
Result: [0.3] Comments
Not Done: Comments
LNMT Low
[0]
High
[0.4]
Unit
mg/dLComments
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952456
Page 41 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.fSponsor ID: [47] Comments
Test: Blood Urea Nitrogen_PX47
Result: [16] Comments
Not Done: Comments
LNMT Low
[5]
High
[28]
Unit
mg/dLComments
5.gSponsor ID: [48] Comments
Test: Creatinine_PX48
Result: [0.9] Comments
Not Done: Comments
LNMT Low
[0.5]
High
[1]
Unit
mg/dLComments
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952457
Page 42 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.HEMATOLOG
Y Huntsville Hospita
l Lab Dec/27/202
0 BLOOD Sponsor-Defined
IdentifierTest:Resu
lt:
1  Not D
one 12.9 
2  Not D
one 38.3 
3  Not D
one 4.39 
5  Not D
one 121 
7  Not D
one 3.4 
608  Not D
one 2.68 
609  Not D
one 0 
612  Not D
one 0.29 
610  Not D
one 0 
611  Not D
one 13.1 Repeating
Pages
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952458
Page 43 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY Comments
2.Laboratory Name and Address [Huntsville Hospital Lab] Comments
3.Collection Date: Dec/27/2020 Comments
4.Specimen Type: BLOOD Comments
Lab Result
5.aSponsor ID: [1] Comments
Test: Hemoglobin_PX1
Result: [12.9] Comments
Not Done: Comments
LNMT Low
[11.5]
High
[14.7]
Unit
g/dLComments
5.bSponsor ID: [2] Comments
Test: Hematocrit_PX2
Result: [38.3] Comments
Not Done: Comments
LNMT Low
[35.2]
High
[44]
Unit
%Comments
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952459
Page 44 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.cSponsor ID: [3] Comments
Test: Erythrocytes_PX3
Result: [4.39] Comments
Not Done: Comments
LNMT Low
[4]
High
[4.9]
Unit
10^6/cu mmComments
5.dSponsor ID: [5] Comments
Test: Platelets_PX5
Result: [121] Comments
Not Done: Comments
LNMT Low
[137]
High
[353]
Unit
10^3/uLComments
5.eSponsor ID: [7] Comments
Test: Leukocytes_PX7
Result: [3.4] Comments
Not Done: Comments
LNMT Low
[4.1]
High
[12.2]
Unit
10^3/uLComments
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952460
Page 45 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.fSponsor ID: [608] Comments
Test: Neutrophils_PX608
Result: [2.68] Comments
Not Done: Comments
LNMT Low
[1.5]
High
[7.9]
Unit
10^3/uLComments
5.gSponsor ID: [609] Comments
Test: Eosinophils_PX609
Result: [0] Comments
Not Done: Comments
LNMT Low
[0]
High
[0.5]
Unit
10^3/uLComments
5.hSponsor ID: [612] Comments
Test: Monocytes_PX612
Result: [0.29] Comments
Not Done: Comments
LNMT Low
[0.3]
High
[1.1]
Unit
10^3/uLComments
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952461
Page 46 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.iSponsor ID: [610] Comments
Test: Basophils_PX610
Result: [0] Comments
Not Done: Comments
LNMT Low
[0]
High
[0.3]
Unit
10^3/uLComments
5.jSponsor ID: [611] Comments
Test: Lymphocytes_PX611
Result: [13.1] Comments
Not Done: Comments
LNMT Low
[0.8]
High
[5.0]
Unit
%Comments
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952462
Page 47 of 478
***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: 10721037 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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952463
Page 48 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952464
Page 49 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Date: Vital Signs Details Form Instance
 1.Dec/29/2020 Record Identifier: Oxygen Saturation
1  97.0 Repeating Pages
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952465
Page 50 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Dec/29/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952466
Page 51 of 478
***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: 10721037 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.Dec/27/2020 18:27  23  Not Done  Repeating Pages
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952467
Page 52 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Oxygenation Parameters
1.Date Time of Assessment: Dec/27/2020 18:27 Comments
2.Arterial Blood Gases PaO2
(mmHg):[23] Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952468
Page 53 of 478
***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: 10721037 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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952469
Page 54 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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
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***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of Asse
ssmentLocation of As
sessmentImaging
MethodOverall AssessmentForm Instan
ce
 1.Dec/27/2020
 CHEST  CT SCAN  ABNORMAL
If abnormal, specify findings:
moderate mixed groundglass and airspace opacities co
nsistent with a COVID pneumonia
 Repeating
Pages
 2.Dec/27/2020
 CHEST  X-RAY  ABNORMAL
If abnormal, specify findings:
bilateral airspace disease, most compatible with multif
ocal pneumonia.
 Repeating
Pages
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952471
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Dec/27/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[moderate mixed groundglass and airspace opacities consistent with a COVID
pneumonia]
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(b) (4)
FDA-CBER-2021-5683-0952472
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Dec/27/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[bilateral airspace disease, most compatible with multifocal pneumonia.]
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(b) (4)
FDA-CBER-2021-5683-0952473
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: 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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021 Comments
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B Comments
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(b) (4)
FDA-CBER-2021-5683-0952474
Page 59 of 478
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.          Repeating
Pages
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952475
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Microbiology Specimen
1.Actual Date of Collection: //
2.Specimen Type:
3.Specimen Collection Location:
4.Assay Code and Description:
5.Device Type:
6.Trade Name:
7.Test Result:
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
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(b) (4)
FDA-CBER-2021-5683-0952476
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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.          Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0952477
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
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(b) (4)
FDA-CBER-2021-5683-0952478
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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.        Repeating Pages
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952479
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
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(b) (4)
FDA-CBER-2021-5683-0952480
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0952481
Page 66 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
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(b) (4)
FDA-CBER-2021-5683-0952482
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952483
Page 68 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
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(b) (4)
FDA-CBER-2021-5683-0952484
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0952485
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
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(b) (4)
FDA-CBER-2021-5683-0952486
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952487
Page 72 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
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(b) (4)
FDA-CBER-2021-5683-0952488
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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.      Repeating Pages
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952489
Page 74 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952490
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952491
Page 76 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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.Start Date: //
6.Ongoing?
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(b) (4)
FDA-CBER-2021-5683-0952492
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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.        Repeating Pages
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952493
Page 78 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Feb/24/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952494
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952495
Page 80 of 478
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 10721037 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/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 [BN68PG]
5.bSample ID [BNW53M]
5.cSample ID [BNW53N]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952496
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***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952497
Page 82 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952498
Page 83 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Nov/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952499
Page 84 of 478
***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: 10721037 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: [ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952500
Page 85 of 478
***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: 10721037 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:
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952501
Page 86 of 478
***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: 10721037 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 [ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952502
Page 87 of 478
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
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).
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with Study
Treatment:
11.Was a Concomitant Medication
given?
12.Was a Non-Drug Treatment given?
13.What was the outcome of this
adverse event?:
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952503
Page 88 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
14.Did the adverse event cause the
subject to be discontinued from the
study?
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952504
Page 89 of 478
***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: 10721037 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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952505
Page 90 of 478
***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: 10721037 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[ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952506
Page 91 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.1  VACCINATIONS  NO  Influenza Vacci
ne Sep/8/20
20 Repeating
Pages
 2.2  VACCINATIONS  NO  Shingrix  Sep/8/20
20 Repeating
Pages
 3.Not Done  Not Done  Not Done  Not Done  Not Don
e Repeating
Pages
 4.Not Done  Not Done  Not Done  Not Done  Not Don
e Repeating
Pages
 5.Not Done  Not Done  Not Done  Not Done  Not Don
e Repeating
Pages
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952507
Page 92 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Influenza Vaccine]
5.Date: Sep/8/2020
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952508
Page 93 of 478
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Shingrix]
5.Date: Sep/8/2020
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952509
Page 94 of 478
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
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.Date: Not Done
//Comments
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952510
Page 95 of 478
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
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.Date: Not Done
//Comments
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952511
Page 96 of 478
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
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.Date: Not Done
//Comments
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952512
Page 97 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defi
ned Identifie
rCategory for MedicationConcomitant Medi
cations Pre-specifi
edName of Me
dicationDose De
scriptio
nForm Insta
nce
 1. DELETED 1  CONCOMITANT IMMUN
OSUPPRESSIVE THERA
PY NO  Remdesivir  100  Repeating
Pages
 2. DELETED   CORTICOSTEROIDS      6  Repeating
Pages
 3. DELETED 3    NO  enoxaparin s
odium 40 mg
 40  Repeating
Pages
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952513
Page 98 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: CONCOMITANT IMMUNOSUPPRESSIVE THERAPY
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Remdesivir ]
5.Dose: [100]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: Dec/28/2020
10.Ongoing? NO
End Date:
Dec/31/2020
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952514
Page 99 of 478
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category: CORTICOSTEROIDS
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]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: INTRAMUSCULAR
9.Start Date: Dec/28/2020
10.Ongoing? NO
End Date:
Jan/7/2021
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952515
Page 100 of 478
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [3]
2.Category:
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[enoxaparin sodium 40 mg ]
5.Dose: [40]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: SUBCUTANEOUS
9.Start Date: Dec/28/2020
10.Ongoing? NO
End Date:
Dec/31/2020
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952516
Page 101 of 478
***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: 10721037 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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952517
Page 102 of 478
***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: 10721037 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?
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952518
Page 103 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952519
Page 104 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952520
Page 105 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952521
Page 106 of 478
***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: 10721037 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:
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952522
Page 107 of 478
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952523
Page 108 of 478
***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: 10721037 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?
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952524
Page 109 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952525
Page 110 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952526
Page 111 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/20/2021
2.Erroneous Visit
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952527
Page 112 of 478
***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: 10721037 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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952528
Page 113 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/20/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952529
Page 114 of 478
***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: 10721037 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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952530
Page 115 of 478
***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: 10721037 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
[ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952531
Page 116 of 478
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/20/2021
2.Erroneous Visit
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952532
Page 117 of 478
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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/20/2021
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952533
Page 118 of 478
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952534
Page 119 of 478
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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/20/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952535
Page 120 of 478
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952536
Page 121 of 478
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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/20/2021
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 [BN68PY]
5.bSample ID [BNW547]
5.cSample ID [BNW548]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952537
Page 122 of 478
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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/20/2021
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 [BN68PZ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952538
Page 123 of 478
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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/20/2021 11:36
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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952539
Page 124 of 478
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952540
Page 125 of 478
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952541
Page 126 of 478
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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:
Mar/11/2021
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 [BN68T8]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952542
Page 127 of 478
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 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: Mar/11/2021 12:25
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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952543
Page 128 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952544
Page 129 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952545
Page 130 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952546
Page 131 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952547
Page 132 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952548
Page 133 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952549
Page 134 of 478
***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: 10721037 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: [ ]
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952550
Page 135 of 478
***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: 10721037 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 Nov/6/2020
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952551
Page 136 of 478
***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: 10721037 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
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952552
Page 137 of 478
***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: 10721037 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 08:56:38 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RandleMiddleton, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952553
Page 138 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormAug-24-2020 17:10:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952554
Page 139 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormDec-30-2020 14:34:59 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952555
Page 140 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Dec-30-2020 14:34:59 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952556
Page 141 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Dec-30-2020 14:34:59 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952557
Page 142 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Dec-30-2020 14:34:59 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952558
Page 143 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Dec-30-2020 14:34:59 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952559
Page 144 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
FormDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952560
Page 145 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Dec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
1Dec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952561
Page 146 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Dec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
2Dec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952562
Page 147 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Dec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
3Dec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952563
Page 148 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Dec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
4Dec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952564
Page 149 of 478
***Confidential***
Header Text: c4591001
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Site No: 1072 Site Name: (1072) Optimal Research, LLC
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Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.aDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (6)
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.aDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (6)
(b) (4), 
(b) (6)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.aDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (6)
(b) (4), 
(b) (6)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.aDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.bDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.bDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
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FDA-CBER-2021-5683-0952570
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.bDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952571
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.bDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952572
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.cDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0952573
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.cDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.cDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.cDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0952576
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.dDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
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FDA-CBER-2021-5683-0952577
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.dDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
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(b) (6)
(b) (4), 
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Page 163 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.dDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
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(b) (4), 
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.dDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
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(b) (4), 
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.eDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.eDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.eDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
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(b) (4), 
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FDA-CBER-2021-5683-0952583
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.eDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
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(b) (6)
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FDA-CBER-2021-5683-0952584
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 fDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5 fDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 fDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5 fDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
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FDA-CBER-2021-5683-0952586
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 fDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5 fDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
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FDA-CBER-2021-5683-0952587
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 fDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5 fDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.gDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.gDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
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(b) (4), 
(b) (6)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.gDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.gDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
(b) (6)
(b) (4), 
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FDA-CBER-2021-5683-0952590
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.gDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
5.gDec-30-2020 14:42:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
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Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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ItemDate User Comment
5.gDec-30-2020 17:01:01 (UTC-06:00) Central
Time (US & Canada)
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Time (US & Canada)Not Done
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(b) (6)
(b) (4), 
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
FormDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0952593
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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ItemDate User Comment
1Dec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
1Dec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0952594
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Dec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
2Dec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Dec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
3Dec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Dec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
4Dec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952597
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.aDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952598
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.aDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952599
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.aDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952600
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.aDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.aDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952601
Page 186 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.bDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952602
Page 187 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.bDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952603
Page 188 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.bDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952604
Page 189 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.bDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.bDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
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(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0952605
Page 190 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.cDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0952606
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.cDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952607
Page 192 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.cDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0952608
Page 193 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.cDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.cDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0952609
Page 194 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.dDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
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FDA-CBER-2021-5683-0952610
Page 195 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.dDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
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FDA-CBER-2021-5683-0952611
Page 196 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.dDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.dDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.dDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0952613
Page 198 of 478
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.eDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
(b) (6)
(b) (4), 
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FDA-CBER-2021-5683-0952614
Page 199 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.eDec-30-2020 14:43:27 (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 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.eDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.eDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.eDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0952617
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 fDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5 fDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952618
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Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
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ItemDate User Comment
5 fDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5 fDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
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(b) (6)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0952619
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 fDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5 fDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0952620
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 fDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5 fDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952621
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.gDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.gDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952622
Page 207 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.gDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.gDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952623
Page 208 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.gDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.gDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952624
Page 209 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.gDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.gDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952625
Page 210 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 hDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5 hDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952626
Page 211 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 hDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5 hDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952627
Page 212 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 hDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5 hDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952628
Page 213 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5 hDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5 hDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952629
Page 214 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.iDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.iDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952630
Page 215 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.iDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.iDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952631
Page 216 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.iDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.iDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952632
Page 217 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.iDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.iDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952633
Page 218 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.jDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.jDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0952634
Page 219 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.jDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.jDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952635
Page 220 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.jDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.jDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0952636
Page 221 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5.jDec-30-2020 17:17:46 (UTC-06:00) Central
Time (US & Canada)
5.jDec-30-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Done
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(b) (4), 
(b) (6)
(b) (4), 
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FDA-CBER-2021-5683-0952637
Page 222 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormDec-30-2020 14:43:56 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0952638
Page 223 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Dec-30-2020 14:43:56 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
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FDA-CBER-2021-5683-0952639
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2.aDec-30-2020 14:43:56 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
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FDA-CBER-2021-5683-0952640
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2.aDec-30-2020 14:43:56 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0952641
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2.aDec-30-2020 14:43:56 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
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FDA-CBER-2021-5683-0952642
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2.aDec-30-2020 14:43:56 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
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FDA-CBER-2021-5683-0952643
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormDec-30-2020 17:26:26 (UTC-06:00) Central
Time (US & Canada)
FormDec-30-2020 14:46:22 (UTC-06:00) Central
Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0952644
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Dec-30-2020 17:26:26 (UTC-06:00) Central
Time (US & Canada)
1Dec-30-2020 14:46:22 (UTC-06:00) Central
Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0952645
Page 230 of 478
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Dec-30-2020 17:26:26 (UTC-06:00) Central
Time (US & Canada)
2Dec-30-2020 14:46:22 (UTC-06:00) Central
Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0952646
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Dec-30-2020 17:31:07 (UTC-06:00) Central
Time (US & Canada)Not Done
3Dec-30-2020 17:26:26 (UTC-06:00) Central
Time (US & Canada)
3Dec-30-2020 14:46:22 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormDec-30-2020 14:47:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Dec-30-2020 14:47:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952649
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Dec-30-2020 14:47:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952650
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Dec-30-2020 14:47:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952651
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Dec-30-2020 14:47:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952652
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Dec-30-2020 14:47:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952653
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6Dec-30-2020 14:47:05 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952654
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Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: DATE OF VISIT - ILLNESS ONSET - 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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Mar-05-2021 14:34:30 (UTC-06:00) Central
Time (US & Canada)not done/not applicable
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952655
Page 240 of 478
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: DATE OF VISIT - ILLNESS ONSET - 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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Mar-04-2021 09:03:37 (UTC-06:00) Central
Time (US & Canada)not done/not applicable
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952656
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormJan-21-2021 08:40:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952657
Page 242 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Jan-21-2021 08:40:48 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952658
Page 243 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Jan-21-2021 08:40:48 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952659
Page 244 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Jan-21-2021 08:40:48 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952660
Page 245 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Jan-21-2021 08:40:48 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952661
Page 246 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Jan-21-2021 08:40:48 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952662
Page 247 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormJan-21-2021 08:41:26 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952663
Page 248 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Jan-21-2021 08:41:26 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952664
Page 249 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Jan-21-2021 08:41:26 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952665
Page 250 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Jan-21-2021 08:41:26 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952666
Page 251 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Jan-21-2021 08:41:26 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952667
Page 252 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Jan-21-2021 08:41:26 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952668
Page 253 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormJan-21-2021 08:39:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952669
Page 254 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Jan-21-2021 08:39:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952670
Page 255 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Jan-21-2021 08:39:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952671
Page 256 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Jan-21-2021 08:39:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952672
Page 257 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Jan-21-2021 08:39:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952673
Page 258 of 478
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Jan-21-2021 08:39:46 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0952674
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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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormMar-02-2021 09:29:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952675
Page 260 of 478
***Confidential***
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Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
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Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Mar-02-2021 09:29:57 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0952676
Page 261 of 478
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Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
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Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormMar-03-2021 09:37:46 (UTC-06:00) Central
Time (US & Canada)Not Done
FormMar-02-2021 09:30:16 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0952677
Page 262 of 478
***Confidential***
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Visit: Disposition Form: DEATH DETAILS CODED - Comments
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Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Mar-03-2021 09:37:46 (UTC-06:00) Central
Time (US & Canada)Not Done
1Mar-02-2021 09:30:16 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0952678
Page 263 of 478
***Confidential***
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Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
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Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormFeb-20-2021 12:38:09 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952679
Page 264 of 478
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Frozen, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Feb-20-2021 12:40:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952680
Page 265 of 478
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 20-Feb-2021 02:14 Form Status: Data Complete, Verified
Site No: 1072 Site Name: (1072) Optimal Research, LLC
Subject No: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Mar-11-2021 14:10:02 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0952681
Page 266 of 478
***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: 10721037 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 08:56:38 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RandleMiddleton, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-05-2021 13:20:33 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Randle
Middleton Approved Mar-04-2021 15:13:57 (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 09:29:57 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952682
Page 267 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Randle
Middleton Approved Feb-25-2021 08:33:41 (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-24-2021 09:06:53 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Randle
Middleton Approved Feb-24-2021 09:01:46 (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-23-2021 16:30:54 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Randle
Middleton Approved Feb-23-2021 15:00:11 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952683
Page 268 of 478
***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: 10721037 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 Feb-17-2021 09:51:08 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Randle
Middleton Approved Jan-28-2021 08:53:23 (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 Jan-25-2021 16:22:52 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Randle
Middleton Approved Jan-21-2021 16:00:15 (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.
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952684
Page 269 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
 N/A Dec-18-2020 10:42:58 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Randle
Middleton Approved Nov-09-2020 18:22:52 (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 Nov-09-2020 12:55:10 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Randle
Middleton Approved Oct-22-2020 07:13:45 (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.
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952685
Page 270 of 478
***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: 10721037 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-24-2020 17:09:42
(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-24-2020 17:09:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952686
Page 271 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-24-2020 17:09:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/24/2020Initial Entry
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952687
Page 272 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-24-2020 17:09:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10721037Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-24-2020 17:04:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1949Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-24-2020 17:10:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-24-2020 17:10:09
(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-24-2020 17:10:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952688
Page 273 of 478
***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: 10721037 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-24-2020 17:10:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952689
Page 274 of 478
***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: 10721037 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-24-2020 17:11:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-24-2020 17:11:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-24-2020 17:11:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0952690
Page 275 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Aug-24-2020 17:30:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Mild Hyperten
sion
Start Date: UNK/UNK/20
05
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-24-2020 17:30:48
(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-24-2020 17:30:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mild HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-24-2020 17:30:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-24-2020 17:30:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4048\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-2021-5683-0952691
Page 276 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b
Date Location User Value Reason
Aug-24-2020 17:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History T
erm:Depression
Start Date: UNK/UNK/2
005
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-24-2020 17:31:08
(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-24-2020 17:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DepressionInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-24-2020 17:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-24-2020 17:31:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae4048\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-2021-5683-0952692
Page 277 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-24-2020 17:32:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Brain Arteriovenou
s Malformation
Start Date: UNK/UNK/2008
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-24-2020 17:32:19
(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-24-2020 17:32:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Brain Arteriovenous Malformati
onInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-24-2020 17:32:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-24-2020 17:32:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-24-2020 17:32:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4Initial Entry
090177e196ae4048\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-2021-5683-0952693
Page 278 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Medical History
Term:Uterine Ablatio
n
Start Date: UNK/UNK/200
4
Ongoing: NO
End Date:
UNK/UNK/
2004
090177e196ae4048\Final\Final On: 01-Apr-2021 05:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0952694
Page 279 of 478
***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: 10721037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.d Line/MH Number:
Date Location User Value Reason
Aug-24-2020 17:32:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 15:59:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Aug-27-2020 08:51:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Aug-26-2020 14:53:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened GDP Clin: Uterine
ablation is reported
but not the
underlying medical
condition that led
to this procedure.
Please add as a
separate entry to
the MH listing.
Aug-24-2020 17:32:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Uterine AblationInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-24-2020 17:32:53
(UTC-06:00) Ce
…[truncated]