125742 S1 M5 CRF c4591001 1121 11211112

Document text

Page 1 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799904
Page 2 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/10/2020
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799905
Page 3 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11211112]
2.Birth Date: /1972
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0799906
Page 4 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799907
Page 5 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799908
Page 6 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799909
Page 7 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTHYROIDISM]
Start Date: UNK/UNK/2014
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERCHOLESTEROLEMIA]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/2016
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TYPE 2 DIABETES]
Start Date: Aug/UNK/2019
Ongoing: YES
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799910
Page 8 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
2.Weight: [189.1]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [29.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799911
Page 9 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/10/2020
2.Randomization Number: [85592]
3.Randomization Group: [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799912
Page 10 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
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 [BP51XM]
5.bSample ID [BPRLSF]
5.cSample ID [BPRLSG]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799913
Page 11 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
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 [BP51XL]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799914
Page 12 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/10/2020 10:01
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
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799915
Page 13 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799916
Page 14 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/29/2020
2.Erroneous Visit
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799917
Page 15 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799918
Page 16 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
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 [BP522B]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799919
Page 17 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/29/2020 09:15
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
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799920
Page 18 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799921
Page 19 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BP525P]
5.bSample ID [BPRM0X]
5.cSample ID [BPRM0Y]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799922
Page 20 of 191
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799923
Page 21 of 191
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799924
Page 22 of 191
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799925
Page 23 of 191
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799926
Page 24 of 191
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799927
Page 25 of 191
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799928
Page 26 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/24/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799929
Page 27 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/24/2020
2.Date of First Symptom Started: Oct/24/2020
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799930
Page 28 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.aSymptoms - Other Text: [Headache]
5.bSymptoms - Other Text: [Slurred speech]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799931
Page 29 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date of C
ollectionSpecimen Typ
eSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
 2.Nov/6/202
0 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799932
Page 30 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799933
Page 31 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/6/2020
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: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT UNKNOWN]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799934
Page 32 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/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 [CV44735]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799935
Page 33 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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:[Telehealth Visit performed. Subject performed self Nasal Swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799936
Page 34 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799937
Page 35 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799938
Page 36 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799939
Page 37 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Covid-19]
Date of Diagnosis:
Nov/6/2020
3.Toxicity Grade: 3
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799940
Page 38 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799941
Page 39 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799942
Page 40 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTest
:Resul
t:Repeating
Pages
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799943
Page 41 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799944
Page 42 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#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
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799945
Page 43 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799946
Page 44 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799947
Page 45 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799948
Page 46 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799949
Page 47 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799950
Page 48 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799951
Page 49 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799952
Page 50 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799953
Page 51 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799954
Page 52 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799955
Page 53 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799956
Page 54 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/04/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/4/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799957
Page 55 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/04/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/4/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP526B]
5.bSample ID [BPRM25]
5.cSample ID [BPRM26]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799958
Page 56 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799959
Page 57 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Unplanned Assessments
1.Assessments
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799960
Page 58 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/27/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799961
Page 59 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799962
Page 60 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799963
Page 61 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799964
Page 62 of 191
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Transient ischaemic
attack Nov/20/2020 UNK:
UNK YES  Repeating
Pages
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799965
Page 63 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Answered Queries, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Transient ischaemic attack]
4.Start Date Time: Nov/20/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Possibly covid related.]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799966
Page 64 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Answered Queries, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020465937]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799967
Page 65 of 191
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categor
yMedication Er
rorStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
 1.          Repeating
Pages
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799968
Page 66 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799969
Page 67 of 191
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799970
Page 68 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799971
Page 69 of 191
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799972
Page 70 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799973
Page 71 of 191
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799974
Page 72 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799975
Page 73 of 191
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799976
Page 74 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799977
Page 75 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799978
Page 76 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799979
Page 77 of 191
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799980
Page 78 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799981
Page 79 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799982
Page 80 of 191
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799983
Page 81 of 191
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799984
Page 82 of 191
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799985
Page 83 of 191
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799986
Page 84 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799987
Page 85 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799988
Page 86 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Mar/1/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799989
Page 87 of 191
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799990
Page 88 of 191
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799991
Page 89 of 191
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799992
Page 90 of 191
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799993
Page 91 of 191
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not Met
Exclusion Criteria Met
2.Description of Exclusion Criterion
Met
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799994
Page 92 of 191
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799995
Page 93 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/27/2020
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799996
Page 94 of 191
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799997
Page 95 of 191
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0799998
Page 96 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormSep-10-2020 15:49:16 (UTC-06:00) Central
Time (US & Canada)INC/EXC meet
Not Applicable
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0799999
Page 97 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormNov-03-2020 13:27:49 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800000
Page 98 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Nov-03-2020 13:27:49 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800001
Page 99 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Nov-03-2020 13:27:49 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800002
Page 100 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Nov-03-2020 13:27:49 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800003
Page 101 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Nov-03-2020 13:27:49 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800004
Page 102 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5Nov-03-2020 13:27:49 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800005
Page 103 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6Nov-03-2020 13:27:49 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800006
Page 104 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
7Nov-03-2020 13:27:49 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800007
Page 105 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
8Nov-03-2020 13:27:49 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800008
Page 106 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
9Nov-03-2020 13:27:49 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800009
Page 107 of 191
***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, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Mar-12-2021 18:17:25 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Daniel Brune  Approved Mar-08-2021 08:55:57 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DanielBrune, 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-01-2021 15:49:51 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Daniel Brune  Approved Jan-21-2021 18:06:47 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DanielBrune, 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.
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800010
Page 108 of 191
***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, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
 N/A Jan-06-2021 17:49:06 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Daniel Brune  Approved Dec-10-2020 14:57:43 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DanielBrune, 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-25-2020 12:35:53 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Daniel Brune  Approved Nov-04-2020 12:29:46 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DanielBrune, 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.
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800011
Page 109 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-10-2020 15:48:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-10-2020 15:48:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800012
Page 110 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-10-2020 15:48:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/10/2020Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800013
Page 111 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-10-2020 15:48:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11211112Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-10-2020 15:48:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1972Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-10-2020 15:48:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-10-2020 15:48:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-10-2020 15:48:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800014
Page 112 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-10-2020 15:49:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800015
Page 113 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-10-2020 15:49:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-10-2020 15:49:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-10-2020 15:49:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800016
Page 114 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Sep-10-2020 15:50:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:HYPERTHYROI
DISM
Start Date: UNK/UNK/2014
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-10-2020 15:50:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 15:50:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERTHYROIDISMInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-10-2020 15:50:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-10-2020 15:50:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800017
Page 115 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Sep-10-2020 15:50:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:HYPERCHOLEST
EROLEMIA
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-10-2020 15:50:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 15:50:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERCHOLESTEROLEMIAInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-10-2020 15:50:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-10-2020 15:50:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-10-2020 15:51:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800018
Page 116 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Medical History T
erm:HYPERTENSI
ON
Start Date: UNK/UNK/20
16
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-10-2020 15:51:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 15:51:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERTENSIONInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-10-2020 15:51:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-10-2020 15:51:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-10-2020 15:51:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:TYPE 2 DIAB
ETES
Start Date: Aug/UNK/2019Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800019
Page 117 of 191
***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: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-10-2020 15:51:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 15:51:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TYPE 2 DIABETESInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-10-2020 15:51:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-10-2020 15:51:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800020
Page 118 of 191
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020 15:52:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-10-2020 15:52:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
189.1Initial Entry
3. Unit:
Date Location User Value Reason
Sep-10-2020 15:52:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-10-2020 15:52:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
67.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-10-2020 15:52:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-10-2020 15:52:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29.6Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800021
Page 119 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7.a
Date Location User Value Reason
Sep-10-2020 15:52:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.3
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-10-2020 15:52:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-10-2020 15:52:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-10-2020 15:52:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-10-2020 15:52:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800022
Page 120 of 191
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-10-2020 15:54:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-10-2020 15:54:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
85592Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800023
Page 121 of 191
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 15:54:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 15:54:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 15:54:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-10-2020 15:54:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-10-2020 15:54:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020 15:54:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP51XMInitial Entry
5.a Sample ID
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800024
Page 122 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Sep-10-2020 15:54:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP51XMInitial Entry
5.b
Date Location User Value Reason
Sep-10-2020 15:55:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRLSFInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-11-2020
19:47:24
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
ClosedAuto closed by
Validation Check:
VC_BEETRK001_01
Sep-11-2020
13:07:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
Answere
dOriginal value is
correct
Sep-10-2020
18:38:03
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
OpenedDMW4669036;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Sep-10-2020
15:55:06
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data En
try:
BPRLSFInitial Entry
5.c
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800025
Page 123 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Sep-11-2020 13:07:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRLSGTranscription Error
Sep-10-2020 15:55:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRLSFInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-11-2020
19:47:24
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
ClosedAuto closed by
Validation Check:
VC_BEETRK001_01
Sep-11-2020
13:07:21
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
Answere
dTranscription Error
Sep-11-2020
13:07:21
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data En
try:
BPRLS
GTranscription Error
Sep-10-2020
18:38:03
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
OpenedDMW4669037;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Sep-10-2020
15:55:20
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data En
try:
BPRLSFInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800026
Page 124 of 191
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 15:55:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 15:55:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 15:55:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-10-2020 15:55:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-10-2020 15:55:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020 15:55:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP51XLInitial Entry
5.a Sample ID
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800027
Page 125 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Sep-10-2020 15:55:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP51XLInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800028
Page 126 of 191
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-10-2020 15:56:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020 15:56:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020 15:56:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-10-2020 15:56:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020 10:01Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020 15:56:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-10-2020 15:56:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800029
Page 127 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7. Route:
Date Location User Value Reason
Sep-10-2020 15:56:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-10-2020 15:56:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-10-2020 15:56:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800030
Page 128 of 191
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-10-2020 15:56:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800031
Page 129 of 191
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-29-2020 12:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800032
Page 130 of 191
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Sep-29-2020 12:03:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020Initial Entry
2.a
Date Location User Value Reason
Sep-29-2020 12:03:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.6
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-29-2020 12:03:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-29-2020 12:03:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
98.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-29-2020 12:03:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800033
Page 131 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Sep-29-2020 12:03:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800034
Page 132 of 191
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020 08:34:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020 08:34:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020 08:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-29-2020 08:34:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-29-2020 08:34:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/29/2020Initial Entry
5.a
Date Location User Value Reason
Sep-29-2020 08:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP522BInitial Entry
5.a Sample ID
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800035
Page 133 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Sep-29-2020 08:34:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP522BInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800036
Page 134 of 191
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-29-2020 12:04:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-29-2020 12:04:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-29-2020 12:04:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-29-2020 12:04:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020 09:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-29-2020 12:04:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-29-2020 12:04:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800037
Page 135 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7. Route:
Date Location User Value Reason
Sep-29-2020 12:04:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-29-2020 12:04:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-29-2020 12:04:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800038
Page 136 of 191
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-27-2020 17:03:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800039
Page 137 of 191
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-27-2020 13:09:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020 13:09:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-27-2020 13:09:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-27-2020 13:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-27-2020 13:09:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-27-2020 13:09:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP525PInitial Entry
5.a Sample ID
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800040
Page 138 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Oct-27-2020 13:09:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP525PInitial Entry
5.b
Date Location User Value Reason
Oct-27-2020 13:09:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRM0XInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-27-2020 13:09:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRM0XInitial Entry
5.c
Date Location User Value Reason
Oct-27-2020 13:10:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRM0YInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-27-2020 13:10:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRM0YInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800041
Page 139 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-17-2021 19:42:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed Response satisfies
query
Feb-17-2021 16:20:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered Data entry complete
Feb-17-2021 13:03:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened Per source, CONV
visit was done on
4Dec20. Please
complete data entry.
Nov-03-2020 13:52:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Erica Weaver Query 3: Closed Response satisfies
query
Nov-03-2020 13:28:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Covid test page
updated
Oct-30-2020 13:19:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened Please update once
data is available.
Oct-30-2020 09:20:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered I have not received
the test result as of
yet. And the trade
name of the swab is
whatever pfizer
provided. When i
have a moment, i
will see about
locating and
answering that field.
It is not on the swab
sample itself.
Oct-29-2020 07:17:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened DM: Kindly review
and complete
‘Microbiology
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800042
Page 140 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Specimen Illness
Details form' at this
visit. Thank you.
Oct-27-2020 17:07:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-27-2020 17:07:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-27-2020 17:06:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in the
Signs and Symptoms
form is missing.
Please review and
update as
appropriate.
Oct-27-2020 17:06:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update as
appropriate.
Oct-27-2020 17:06:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/24/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-27-2020 17:06:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800043
Page 141 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/24/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/24/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-18-2021 01:28:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-17-2021 16:22:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject has ongoing
SAE. I updated
symptoms that were
affecting him at the
time of the Conv
visit and are still
ongoing. Please
advise if this is not
where you want this
information
Feb-15-2021 05:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Please confirm the
symptoms are still
ongoing for this
COVID Illness. If
all symptoms for
this illness are
resolved; please
update the Last
Symptoms Resolved
Date else clarify.
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800044
Page 142 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-27-2020 17:07:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Feb-17-2021 16:19:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOChanged Information
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Feb-17-2021 16:19:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOChanged Information
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Feb-17-2021 16:19:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:NOChanged Information
Dec-05-2020 19:54:00
(UTC-06:00) Central TimeACV0PFEINFP6000  Data Entry: New Information
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0800045
Page 143 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(US & Canada) Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:YES
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-17-2021 16:19:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOChanged Information
Dec-08-2020 15:21:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-05-2020 19:54:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Dec-05-2020 19:54:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESNew Information
Dec-02-2020 16:32:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Subject reported new
symptom of cough
per progress note on
24Nov20. Please
consider updating.
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800046
Page 144 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
4.c
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREASED
SHORTNESS OF BREA
TH
Sympto
m Presen
t:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORTNE
SS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800047
Page 145 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
4.d Symptoms:
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Feb-17-2021 16:19:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAIN
Symptom
Present:NOTranscription Error
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAIN
Symptom
Present:YESInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800048
Page 146 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
4.e Symptoms:
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSCLE P
AINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-17-2021 16:19:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: NEW LOSS OF TAST
E OR SMELL
Symptom P
resent:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SMEL
LInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800049
Page 147 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCREASE
D SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE TH
ROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Feb-17-2021 16:19:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOChanged Information
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHEA
Symptom Present: YESInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800050
Page 148 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
4.h Symptoms:
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-17-2021 16:19:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOChanged Information
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.i
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-27-2020 17:07:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800051
Page 149 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-27-2020 17:07:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other: HeadacheInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Oct-27-2020 17:07:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HeadacheInitial Entry
5.b
Date Location User Value Reason
Mar-02-2021 17:57:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other
:Slurred speec
hTranscription Error
Feb-17-2021 16:20:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
- Other:Slurred speech, possibl
y secondary to covid.Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800052
Page 150 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.b Symptoms - Other Text:
Date Location User Value Reason
Mar-03-2021
09:27:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 4: Closed Response
satisfies query
Mar-02-2021
21:35:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 3: Closed Discrepancy has
been closed.
Mar-02-2021
17:57:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Answe
redTranscription
Error
Mar-02-2021
17:57:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answe
redTranscription
Error
Mar-02-2021
17:57:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Slurred speechTranscription
Error
Feb-23-2021
15:44:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 4: Opene
dClin: Please
record symptom
only, eg slurred
speech, on this
CRF as
COVID-19
diagnosis is
already recorded
on ILL POTEN
CRF.
Feb-21-2021
09:39:23
(UTC-06:00)
Central Time (USACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 3: Opene
dMultiple actions
for SLURRED
SPEECH,
POSSIBLY
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800053
Page 151 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
& Canada) SECONDARY
TO COVID. Are
you reporting
SLURRED
SPEECH,
POSSIBLY
SECONDARY
TO COVID-19?
If so, update the
verbatim term as
such and split the
term into
SLURRED
SPEECH and
COVID-19 and
submit
separately.
Otherwise clarify
and edit the
verbatim term
accordingly.
Thank you.
Feb-21-2021
09:30:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 2: Closed Discrepancy has
been closed.
Feb-21-2021
04:51:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 2: Opene
dMultiple actions
for SLURRED
SPEECH,
POSSIBLY
SECONDARY
TO COVID. Are
you reporting
SLURRED
SPEECH,
POSSIBLY
SECONDARY
TO COVID-19?
If so, update the
verbatim term as
such and split the
term into
SLURRED
SPEECH and
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800054
Page 152 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
COVID-19 and
submit
separately.
Otherwise clarify
and edit the
verbatim term
accordingly.
Thank you.
Feb-21-2021
03:01:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Feb-19-2021
10:50:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answe
redThis subject has
ongoing SAE.
Covid was
confirmed when
subject was
hospitalized.
Subject still
experiencing
re-occurring
headaches and
slurred speech.
When subject
was in the
hospital stroke
protocol was
followed, though
ruled out.
Feb-18-2021
03:12:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Opene
dMultiple actions
for SLURRED
SPEECH,
POSSIBLY
SECONDARY
TO COVID. Are
you reporting
SLURRED
SPEECH,
POSSIBLY
SECONDARY
TO COVID-19?
If so, update the
verbatim term as
such and split the
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800055
Page 153 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
term into
SLURRED
SPEECH and
COVID-19 and
submit
separately.
Otherwise clarify
and edit the
verbatim term
accordingly.
Thank you.
Feb-17-2021
16:20:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Slurred speech,
possibly second
ary to covid.Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800056
Page 154 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Oct-30-2020 09:16:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800057
Page 155 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Dec-05-2020 20:15:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800058
Page 156 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Dec-08-2020 15:23:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-05-2020 19:41:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject has not
provided lab report.
Medical records have
been requested.
Dec-01-2020 19:11:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened According to SAE
report, subject was
tested positive on
6Nov2020. Please
provide lab report
and update EDC.
Nov-03-2020 13:27:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Nov-03-2020 13:27:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Oct-30-2020 09:16:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/24/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-03-2020 13:27:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Nov-03-2020 13:27:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Oct-30-2020 09:16:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800059
Page 157 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
3. Specimen Collection Location:
Date Location User Value Reason
Nov-03-2020 13:51:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Erica Weaver Query 1: Closed Response satisfies
query
Nov-03-2020 13:27:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Nov-03-2020 13:27:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Nov-03-2020 07:13:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered The trade name is
provided. I'm not
sure what else i
would enter in this
field. I have not
received the results.
Once they are
provided, i will
update accordingly.
Nov-03-2020 03:24:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM1: Please
consider to complete
item# 7 (Test Result)
as well. Thanks
Nov-02-2020 18:39:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered 7 is NA
Nov-01-2020 22:57:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Please
complete item # 6, 7.
Thank you.
Oct-30-2020 09:16:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-03-2020 13:27:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not DoneInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800060
Page 158 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-03-2020 13:27:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Oct-30-2020 09:16:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Nov-03-2020 13:27:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not DoneInitial Entry
Nov-03-2020 13:27:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Oct-30-2020 09:16:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Nov-03-2020 13:27:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Nov-03-2020 13:27:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Nov-02-2020 15:52:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CDC 2019-NCOV REAL-TIME RT
-PCR DIAGNOSTIC PANELInitial Entry
7. Test Result:
Date Location User Value Reason
Nov-03-2020 13:27:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800061
Page 159 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Nov-03-2020 13:27:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Nov-03-2020 13:27:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800062
Page 160 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Dec-05-2020 20:16:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-05-2020 20:16:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/6/2020Transcription Error
Dec-05-2020 20:15:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date entered is in the
future compared to
today's date. Please
correct.
Dec-05-2020 20:15:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/6/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Dec-05-2020 20:15:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Dec-05-2020 20:15:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Dec-05-2020 20:15:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800063
Page 161 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Dec-05-2020 20:15:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TESTInitial Entry
6. Trade Name:
Date Location User Value Reason
Jan-13-2021 09:52:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 3: Closed Response satisfies
query
Jan-11-2021 19:44:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Answered per query
Jan-10-2021 14:08:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 3: Reissued:Opened Clin: If the Trade
Name is not known,
enter “NALT
Unknown” in the
section "Trade Name
Other, Specify:"
Jan-08-2021 10:07:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered NALT-UNKNOWN is
not an option.
Jan-08-2021 10:07:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERNALT-UNKNOWN is
not an option.
Jan-07-2021 20:19:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 4: Closed Response satisfies
query
Jan-07-2021 20:18:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
Jan-07-2021 20:18:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 2: Closed Response satisfies
query
Jan-07-2021 20:18:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 3: Reissued:Opened Clin: please enter
"NALT-UNKNOWN"
instead of
UNKNOWN
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800064
Page 162 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jan-06-2021 17:49:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered NALT-UNKNOWN.
Subject was given an
NAAT worksheet, but
it has not been
returned.
Jan-06-2021 17:49:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered NALT-UNKNOWN.
Subject was given an
NAAT worksheet, but
it has not been
returned.
Jan-06-2021 17:49:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: NALT-UNKNOWN.
Subject was given an
NAAT worksheet, but
it has not been
returned.
Jan-06-2021 17:48:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject was given an
NAAT worksheet, but
it has not been
returned.
Jan-05-2021 13:11:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered NAAT Test worksheet
was completed and
never received. Will
follow up with CRA
Dec-06-2020 22:27:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 4: Opened Clin: For guidance
how to complete this
CRF form, please
refer to the CRF
COMPLETION
REQUIREMENTS
FOR INFORM section
8.31.7. page 138
Dec-06-2020 22:27:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 3: Opened If the Trade Name is
not is not available,
and if it is not known
whether the test was
performed in a CLIA-
certified laboratory or
in a laboratory
accredited by the ISO
15189 standard by a
national or regional
accredited body,
please enter “NALT
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800065
Page 163 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Unknown”
Dec-06-2020 22:26:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 2: Opened Clin: If
manufacturer/test kit
name is not available,
please indicate
whether the test was
performed by a
laboratory accredited
by the ISO 15189
standard by including
the text ‘ISO 15189
accredited lab’ (ie
SARS-CoV-2 test ISO
15189 accredited lab)
Dec-06-2020 22:26:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: If
manufacturer/test kit
name is not available,
please indicate
whether the test was
conducted in a CLIA-
certified laboratory by
including the text
‘CLIA-certified lab’
(ie SARS-CoV-2 test
CLIA-certified lab)
Dec-05-2020 20:15:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Dec-05-2020 20:15:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
POSITIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Jan-11-2021 19:44:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NALT UNKNOWNAnswered per query
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800066
Page 164 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-05-2020 20:15:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UnknownInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800067
Page 165 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-27-2020 17:07:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020 17:07:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-27-2020 17:07:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-27-2020 17:07:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-27-2020 17:07:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/24/2020Initial Entry
5.a
Date Location User Value Reason
Oct-27-2020 17:07:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: CV44735Initial Entry
5.a Sample ID
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800068
Page 166 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Oct-27-2020 17:07:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CV44735Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800069
Page 167 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-27-2020 17:09:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-27-2020 17:09:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-27-2020 17:09:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Oct-27-2020 17:09:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Telehealth Visit performed. Subject
performed self Nasal SwabInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800070
Page 168 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIAL
IST
Occurrence of Visits or
Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitione
r:EMERGENC
Y ROOM
Occurrence of Visit
s or Contacts:NOInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800071
Page 169 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitio
ner:PRIMARY CAR
E PHYSICIAN
Occurrence of Vi
sits or Contacts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: URGENTInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800072
Page 170 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
CARE
Occurrence of Visits o
r Contacts:NO
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitio
ner:TELEPHONE C
ONSULTATION
Occurrence of Vi
sits or Contacts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800073
Page 171 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or Co
ntacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Oct-27-2020 17:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800074
Page 172 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Oct-30-2020 16:14:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Feb-02-2021 07:24:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Feb-01-2021 15:49:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered New Information
Feb-01-2021 15:49:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness Diagnosis:
Covid-19
Date of Diagnosis:
Nov/6/2020New Information
Jan-28-2021 00:59:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened Thanks for the
response, form has
been unfreeze, please
update as per below
query
Jan-27-2021 17:45:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Page is locked, and
cannot be changed.
Jan-23-2021 13:39:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Clin: As subject is
symptomatic and has
a positive local swab
collected on
06Nov2020,
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0800075
Page 173 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
diagnosis of
"COVID-19" should
be recorded. See
CRF CRs Section
8.33.3 for details.
Dec-16-2020 23:09:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-05-2020 19:54:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Dec-01-2020 19:15:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened According to the
progress note in the
SAE report, subject
was tested positive
on 6Nov2020. Since
symptoms are still
ongoing, please
confirm if diagnosis
should be updated.
Oct-30-2020 16:14:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Nov-02-2020 20:30:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-02-2020 18:38:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Nov-02-2020 18:38:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
Nov-01-2020 14:55:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical Query: Per
CRF CRs Section
8.33.5, please enter
worst toxicity grade
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800076
Page 174 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/24/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(1 to 5) as it relates
to reported
symptom(s) on SOD
CRF.
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800077
Page 175 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/04/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-17-2021 16:17:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/4/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-17-2021 16:17:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800078
Page 176 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/04/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-17-2021 16:17:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-17-2021 16:17:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-17-2021 16:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-17-2021 16:17:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Feb-17-2021 16:17:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/4/2020Initial Entry
5.a
Date Location User Value Reason
Feb-17-2021 16:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP526BInitial Entry
5.a Sample ID
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800079
Page 177 of 191
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/04/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Feb-17-2021 16:18:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP526BInitial Entry
5.b
Date Location User Value Reason
Feb-17-2021 16:18:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRM25Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-17-2021 16:18:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPRM25Initial Entry
5.c
Date Location User Value Reason
Feb-17-2021 16:18:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRM26Initial Entry
5.c Sample ID
Date Location User Value Reason
Feb-17-2021 16:18:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPRM26Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800080
Page 178 of 191
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-27-2020 17:03:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-27-2020 17:03:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-27-2020 17:03:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800081
Page 179 of 191
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Nov-25-2020 12:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800082
Page 180 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Answered Queries, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Nov-25-2020 12:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-25-2020 12:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-06-2020 22:25:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
Dec-05-2020 20:19:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Lab result added to
potential covid-19
CRF form. Medical
records requested,
not yet received.
Subject does not
know the trade name
of the test.
Dec-02-2020 15:47:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Reissued:Opened Clin: Please enter the
local SARS-CoV-2
lab result on the
potential COVID-19
CRF form
Dec-02-2020 11:43:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject had a
telehealth visit on
10/24/2020. Subject
reported symptoms
then and self swab
was conducted and
sent to the lab.
Subject was still
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800083
Page 181 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Answered Queries, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
having Covid illness
symptoms when
SAE occurred. This
is all one continuous
illness.
Dec-01-2020 10:26:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: It was stated in
the SAE report
#2020465937 that
the subject has a
positive
SARS-CoV-2 test
result on
06Nov2020. Please
capture this
information on a
potential COVID-19
visit CRF forms and
if the subject was
symptomatic please
conduct a visit.
Nov-25-2020 12:35:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Transient ischaemic attackInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-25-2020 12:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/20/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-12-2021 18:20:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Subject had
suspected TIA.
However diagnostic
tests did not show he
actually had TIA.
Subject suffering
from Neurologic
issues, secondary to
covid. Suspected
TIA is what subject
was admitted for.
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800084
Page 182 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Answered Queries, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Mar-09-2021 13:56:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Juleen Gayed Query 2: Opened Clin: Please confirm
if this is still ongoing
as by definition TIA
should resolve within
24 hours, consider if
SAE term should be
updated and if so
please send updated
SAE report
Jan-06-2021 09:39:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-05-2021 12:54:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Yes. Event is still
ongoing. Event term
may change, but
event definitely
ongoing.
Dec-21-2020 13:13:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please determine if
this Adverse Event is
still ONGOING as it
has been 32 Days
since Onset Date.
Please update or
confirm. If updated,
please ensure an
updated SAE Report
is also submitted.
Nov-25-2020 12:35:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-08-2020 12:53:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-05-2020 19:42:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Dec-05-2020 19:42:36
(UTC-06:00) Central TimeACV0PFEINFP6000  Data Entry:
3Transcription Error
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0800085
Page 183 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Answered Queries, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(US & Canada)
Dec-02-2020 16:44:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 3 per source. Please
confirm and correct
as necessary.
Nov-25-2020 12:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-26-2020 03:52:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-25-2020 12:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Transient
ischaemic attack:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Nov-25-2020 12:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated wit
h congenital anomaly or birth defe
ct?
NO
Did this serious event result in dea
th?
NO
Did this serious event require or p
rolong hospitalization?Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800086
Page 184 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Answered Queries, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
YES
Did this serious event result in per
sistent or significant disability/inc
apacity?
NO
Is this serious event life threatenin
g?
NO
Other medically important serious
event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-25-2020 12:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-02-2020 13:13:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-02-2020 11:44:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject is due in for
his convalescent
illness visit.
Telehealth visit
initially performed
on 10/24
Nov-30-2020 09:51:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY: For
this SAE - Transient
Ischaemic Attack,
please clarify this
Relationship of
POSSIBLE COVID
RELATED and
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800087
Page 185 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Answered Queries, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
determine if a
COVID ILLNESS
Visit should be
performed. Please
update or clarify.
Nov-25-2020 12:35:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
Possibly covid related.Initial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-25-2020 12:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-25-2020 12:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-25-2020 12:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Mar-13-2021
03:13:38
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7698955;Response
to "What was the
outcome of this adverse
event?" is
'Recovered/Resolved' or
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800088
Page 186 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Answered Queries, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Canada) 'Recovered/Resolved
with Sequelae' but End
Date/Time is missing.
Please review and update
as appropriate.
Mar-12-2021
18:17:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
REC
OVE
RED/
RESO
LVEDSubject had suspected
TIA. Per diagnostic tests,
TIA was not diagnosed.
Nov-25-2020
12:35:53
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
NOT
REC
OVE
RED/
NOT
RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-25-2020 12:35:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-26-2020 03:52:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2020465937Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800089
Page 187 of 191
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-01-2021 18:40:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/1/2021Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800090
Page 188 of 191
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-01-2021 18:40:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-01-2021 18:40:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Mar-01-2021 18:40:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for V
accination 3
Participant is:
eligible per other protocol allow
ance(s) and confirmed to have r
eceived only placebo at Vaccinat
ion 1/2Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800091
Page 189 of 191
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-01-2021 18:40:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/1/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-01-2021 18:40:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR ADDI
TIONAL VACCINATIONInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800092
Page 190 of 191
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-27-2020 17:03:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-10-2020 15:54:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-10-2020 15:49:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-26-2020 03:52:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Event added in Inform
Nov-25-2020 05:46:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020465937
Hospitalization for possible
mini stroke(onset
date:20Nov2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-27-2020 17:03:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/27/2020Initial Entry
Sep-10-2020 15:54:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
Sep-10-2020 15:49:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0800093
Page 191 of 191
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1121 Site Name: (1121) Optimal Research
Subject No: 11211112 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-04-2020 12:29:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Daniel
BruneData Entry:
Click Here to EnableInitial Entry
090177e196ae30cc\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800094