Document text
Page 1 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957733
Page 2 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/4/2020
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957734
Page 3 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Demography
1.Subject ID [10831029]
2.Birth Date: 1970
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:
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0957735
Page 4 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/4/2020
2.Erroneous Visit
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957736
Page 5 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957737
Page 6 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957738
Page 7 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergic rhinitis]
Start Date: UNK/UNK/2013
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gastroesophageal reflux disease]
Start Date: UNK/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[heartburn]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tonsillitis]
Start Date: UNK/UNK/1993
Ongoing: NO
End Date:
UNK/UNK/1993
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957739
Page 8 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[obesity]
Start Date: UNK/UNK/2004
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anxiety]
Start Date: Nov/UNK/2019
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bilateral carpal tunnel syndrome]
Start Date: UNK/UNK/2002
Ongoing: NO
End Date:
UNK/UNK/2003
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Intermittent Headache] Comments
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957740
Page 9 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chronic sinus infection]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/2011
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[balloon sinuplasty]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bilateral carpal tunnel repair]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergy to oak]
Start Date: UNK/UNK/2013
Ongoing: YES
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957741
Page 10 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergy to cedar]
Start Date: UNK/UNK/2013
Ongoing: YES
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957742
Page 11 of 543
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Aug/4/2020
2.Weight: [290.8]
3.Unit: LB
4.Height: [71.0]
5.Unit: in
6.Body Mass Index: [40.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957743
Page 12 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/4/2020
2.Randomization Number: [41608]
3.Randomization Group: [ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957744
Page 13 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/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 [BG1VJK]
5.bSample ID [BG1VJL]
5.cSample ID [BP6V1Y]
5.dSample ID [BP6V1Z]
5.eSample ID [BP6V20]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957745
Page 14 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/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 [BP6V2C]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957746
Page 15 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/4/2020 12:21
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
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957747
Page 16 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957748
Page 17 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020 Comments
2.Erroneous Visit Comments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957749
Page 18 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957750
Page 19 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957751
Page 20 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957752
Page 21 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957753
Page 22 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?Not Done Comments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957754
Page 23 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957755
Page 24 of 543
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?Not Applicable Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957756
Page 25 of 543
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
3.Injection Site Location: Not Applicable Comments
4.Injection Site Body Side: Not Applicable Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957757
Page 26 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/2/2020
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 [BPZ1N6]
5.bSample ID [BLCJYX]
5.cSample ID [BLCJYY]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957758
Page 27 of 543
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957759
Page 28 of 543
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/26/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BKN2L9]
5.bSample ID [BM3MF9]
5.cSample ID [BM3MFN]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957760
Page 29 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957761
Page 30 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957762
Page 31 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957763
Page 32 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957764
Page 33 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957765
Page 34 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/9/2020
2.Date of First Symptom Started: Nov/7/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/12/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
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
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957766
Page 35 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Symptoms - Other
5.aSymptoms - Other Text: [Body Aches]
5.bSymptoms - Other Text: [Runny Nose/Drainage] Comments
5.cSymptoms - Other Text: [Chest Congestion] Comments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957767
Page 36 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Nov/5/202
0 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
2.Nov/8/202
0 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957768
Page 37 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/5/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: ABBOTT DIAGNOSTICS ID NOW COVID-19 Comments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [per urgent care records subject was COVID Asymptomatic] Comments
9.Trade Name Other, Specify: [ ] Comments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957769
Page 38 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/8/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: ABBOTT DIAGNOSTICS ID NOW COVID-19
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957770
Page 39 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Self swab not done. PI performed swab at this office visit]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957771
Page 40 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/9/2020
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 [BP21XG]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957772
Page 41 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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: YES
Number of Visits or Contacts:
[2]Comments
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
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957773
Page 42 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957774
Page 43 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957775
Page 44 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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/8/2020Comments
3.Toxicity Grade: 1
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957776
Page 45 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable
Repeating Pages
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957777
Page 46 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957778
Page 47 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable
Not Appli
cable Not Applic
able Not Applic
able Sponsor-Defined
IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957779
Page 48 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957780
Page 49 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957781
Page 50 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957782
Page 51 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957783
Page 52 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
1.Not Applicabl
e Not Applicable Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable
Not Applicable Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957784
Page 53 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957785
Page 54 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957786
Page 55 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957787
Page 56 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957788
Page 57 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957789
Page 58 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957790
Page 59 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Date: Vital Signs Details Form Instance
1.Nov/9/2020 Record Identifier: Systolic: Diastolic:
1 139 86 Repeating Pages
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957791
Page 60 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [139]
Diastolic: [86]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [57]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957792
Page 61 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957793
Page 62 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957794
Page 63 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1.Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957795
Page 64 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957796
Page 65 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable
Not Applic
able Repeating
Pages
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957797
Page 66 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957798
Page 67 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957799
Page 68 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957800
Page 69 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/07/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/7/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957801
Page 70 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/7/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCJ52]
5.bSample ID [BLBR8D]
5.cSample ID [BLBR8F]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957802
Page 71 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957803
Page 72 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Unplanned Assessments
1.Assessments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957804
Page 73 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Aug/23/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957805
Page 74 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957806
Page 75 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957807
Page 76 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957808
Page 77 of 543
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Paroxysmal Atrial fibrillation with
rapid ventricular response Aug/23/2020
UNK:UNK NO
End Date Time:
Sep/8/2020 00:00
Repeating
Pages
2.ADVERSE
EVENT 2 Left Ventricular Hypertrophy Aug/24/2020 0
0:00 YES Repeating
Pages
3.ADVERSE
EVENT 3 Hypertension Aug/24/2020 0
0:00 YES Repeating
Pages
4.ADVERSE
EVENT 4 Atrial Flutter Sep/2/2020 00:
00 NO
End Date Time:
Sep/8/2020 00:00
Repeating
Pages
5.ADVERSE
EVENT 5 Laceration-Left Index Finger Sep/1/2020 00:
00 NO
End Date Time:
Sep/15/2020 00:00
Repeating
Pages
6.ADVERSE
EVENT 6 Prior Septual Myocardinal Infarctio
n Sep/8/2020 00:
00 NO
End Date Time:
Sep/8/2020 00:00
Repeating
Pages
7.ADVERSE
EVENT 7 Mitral Regurgitation Sep/9/2020 00:
00 YES Repeating
Pages
8.ADVERSE
EVENT 8 Bileaflet mitral valve prolapse Sep/9/2020 00:
00 YES Repeating
Pages
9.ADVERSE
EVENT 9 Left Atrial Enlargement Sep/9/2020 00:
00 YES Repeating
Pages
10.ADVERSE
EVENT 10 Ear Pain Dec/4/2020 00:
00 YES Repeating
Pages
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957809
Page 78 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[Paroxysmal Atrial fibrillation with rapid ventricular response]
4.Start Date Time: Aug/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/8/2020 00:00
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
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957810
Page 79 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:
[Heart Disease]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES Comments
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[2020330413]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957811
Page 80 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Left Ventricular Hypertrophy]
4.Start Date Time: Aug/24/2020 00:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Medical Illness]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957812
Page 81 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957813
Page 82 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Hypertension]
4.Start Date Time: Aug/24/2020 00:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Medical Illness]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957814
Page 83 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957815
Page 84 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Atrial Flutter]
4.Start Date Time: Sep/2/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/8/2020 00:00
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).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:
[Cardiac Disease]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957816
Page 85 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957817
Page 86 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Laceration-Left Index Finger]
4.Start Date Time: Sep/1/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/15/2020 00:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[Hobby Injury]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957818
Page 87 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?: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[ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957819
Page 88 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Prior Septual Myocardinal Infarction]
4.Start Date Time: Sep/8/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/8/2020 00:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Heart Disease]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957820
Page 89 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957821
Page 90 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Mitral Regurgitation]
4.Start Date Time: Sep/9/2020 00:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Heart Disease]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957822
Page 91 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957823
Page 92 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Bileaflet mitral valve prolapse]
4.Start Date Time: Sep/9/2020 00:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Heart Disease]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957824
Page 93 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957825
Page 94 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Left Atrial Enlargement]
4.Start Date Time: Sep/9/2020 00:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Heart Disease]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957826
Page 95 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957827
Page 96 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [10]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Ear Pain]
4.Start Date Time: Dec/4/2020 00:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Strep Prevention]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957828
Page 97 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957829
Page 98 of 543
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957830
Page 99 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957831
Page 100 of 543
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957832
Page 101 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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: //
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957833
Page 102 of 543
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957834
Page 103 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957835
Page 104 of 543
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957836
Page 105 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957837
Page 106 of 543
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957838
Page 107 of 543
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957839
Page 108 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957840
Page 109 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957841
Page 110 of 543
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957842
Page 111 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957843
Page 112 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957844
Page 113 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957845
Page 114 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957846
Page 115 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957847
Page 116 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957848
Page 117 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957849
Page 118 of 543
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957850
Page 119 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/13/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957851
Page 120 of 543
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957852
Page 121 of 543
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957853
Page 122 of 543
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957854
Page 123 of 543
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: Not Done Comments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957855
Page 124 of 543
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Done
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Done
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957856
Page 125 of 543
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Not Done
//Comments
2.Phase of Disposition: Not Done Comments
3.Status: Not Done Comments
4.Specify Status: Not Done
[ ]Comments
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957857
Page 126 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Aug/23/2020
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957858
Page 127 of 543
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957859
Page 128 of 543
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Laurence Chu Approved Mar-11-2021 17:09:37 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LaurenceChu, 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.
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0957860
Page 129 of 543
***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: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormAug-06-2020 15:53:15 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957861
Page 130 of 543
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1 hAug-10-2020 12:31:12 (UTC-06:00) Central
Time (US & Canada)Intermittent- will be added to Medical History.
Per ConMed list subject takes pain relievers as
needed for Headaches.
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957862
Page 131 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormOct-07-2020 17:44:37 (UTC-06:00) Central
Time (US & Canada)
FormOct-05-2020 10:46:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957863
Page 132 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Oct-07-2020 17:44:37 (UTC-06:00) Central
Time (US & Canada)
1Oct-05-2020 10:46:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957864
Page 133 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Oct-07-2020 17:44:37 (UTC-06:00) Central
Time (US & Canada)
2Oct-05-2020 10:46:46 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957865
Page 134 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormOct-09-2020 09:03:04 (UTC-06:00) Central
Time (US & Canada)Subject did not completed V2- Per PI due to
SAE and instability of his medical conditions PI
decision for subject not to have vaccination 2.
Swab was not obtained on this SAE follow up
visit
Not Done
FormOct-09-2020 08:50:04 (UTC-06:00) Central
Time (US & Canada)
FormOct-07-2020 17:41:49 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957866
Page 135 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Oct-09-2020 09:03:04 (UTC-06:00) Central
Time (US & Canada)Subject did not completed V2- Per PI due to SAE
and instability of his medical conditions PI
decision for subject not to have vaccination 2.
Swab was not obtained on this SAE follow up
visit
Not Done
1Oct-09-2020 08:50:04 (UTC-06:00) Central
Time (US & Canada)
1Oct-07-2020 17:41:49 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957867
Page 136 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Oct-09-2020 09:03:04 (UTC-06:00) Central
Time (US & Canada)Subject did not completed V2- Per PI due to SAE
and instability of his medical conditions PI
decision for subject not to have vaccination 2.
Swab was not obtained on this SAE follow up
visit
Not Done
2Oct-09-2020 08:50:04 (UTC-06:00) Central
Time (US & Canada)
2Oct-07-2020 17:41:49 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957868
Page 137 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Oct-09-2020 09:03:04 (UTC-06:00) Central
Time (US & Canada)Subject did not completed V2- Per PI due to SAE
and instability of his medical conditions PI
decision for subject not to have vaccination 2.
Swab was not obtained on this SAE follow up
visit
Not Done
3Oct-09-2020 08:50:04 (UTC-06:00) Central
Time (US & Canada)
3Oct-07-2020 17:41:49 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957869
Page 138 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Oct-09-2020 09:03:04 (UTC-06:00) Central
Time (US & Canada)Subject did not completed V2- Per PI due to SAE
and instability of his medical conditions PI
decision for subject not to have vaccination 2.
Swab was not obtained on this SAE follow up
visit
Not Done
4Oct-09-2020 08:50:04 (UTC-06:00) Central
Time (US & Canada)
4Oct-07-2020 17:41:49 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957870
Page 139 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormOct-07-2020 17:41:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957871
Page 140 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Oct-07-2020 17:41:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957872
Page 141 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Oct-07-2020 17:41:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957873
Page 142 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Oct-07-2020 17:41:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957874
Page 143 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Oct-07-2020 17:41:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957875
Page 144 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5Oct-07-2020 17:41:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957876
Page 145 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6Oct-07-2020 17:41:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957877
Page 146 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
7Oct-07-2020 17:41:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957878
Page 147 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
8Oct-07-2020 17:41:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957879
Page 148 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
9Oct-07-2020 17:41:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957880
Page 149 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
10Oct-07-2020 17:41:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957881
Page 150 of 543
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
11Oct-07-2020 17:41:30 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957882
Page 151 of 543
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormOct-02-2020 17:09:53 (UTC-06:00) Central
Time (US & Canada)Subject did not get vaccination 2- PI decision
secondary to SAE and unstable medical
condition at last office visit
Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957883
Page 152 of 543
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Oct-02-2020 17:09:53 (UTC-06:00) Central
Time (US & Canada)Subject did not get vaccination 2- PI decision
secondary to SAE and unstable medical
condition at last office visit
Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957884
Page 153 of 543
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.aOct-02-2020 17:09:53 (UTC-06:00) Central
Time (US & Canada)Subject did not get vaccination 2- PI decision
secondary to SAE and unstable medical
condition at last office visit
Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957885
Page 154 of 543
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.bOct-02-2020 17:09:53 (UTC-06:00) Central
Time (US & Canada)Subject did not get vaccination 2- PI decision
secondary to SAE and unstable medical
condition at last office visit
Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957886
Page 155 of 543
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.cOct-02-2020 17:09:53 (UTC-06:00) Central
Time (US & Canada)Subject did not get vaccination 2- PI decision
secondary to SAE and unstable medical
condition at last office visit
Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957887
Page 156 of 543
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.dOct-02-2020 17:09:53 (UTC-06:00) Central
Time (US & Canada)Subject did not get vaccination 2- PI decision
secondary to SAE and unstable medical
condition at last office visit
Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957888
Page 157 of 543
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.eOct-02-2020 17:09:53 (UTC-06:00) Central
Time (US & Canada)Subject did not get vaccination 2- PI decision
secondary to SAE and unstable medical
condition at last office visit
Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957889
Page 158 of 543
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2 fOct-02-2020 17:09:53 (UTC-06:00) Central
Time (US & Canada)Subject did not get vaccination 2- PI decision
secondary to SAE and unstable medical
condition at last office visit
Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957890
Page 159 of 543
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.gOct-02-2020 17:09:53 (UTC-06:00) Central
Time (US & Canada)Subject did not get vaccination 2- PI decision
secondary to SAE and unstable medical
condition at last office visit
Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957891
Page 160 of 543
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2 hOct-02-2020 17:09:53 (UTC-06:00) Central
Time (US & Canada)Subject did not get vaccination 2- PI decision
secondary to SAE and unstable medical
condition at last office visit
Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957892
Page 161 of 543
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Oct-02-2020 17:09:53 (UTC-06:00) Central
Time (US & Canada)Subject did not get vaccination 2- PI decision
secondary to SAE and unstable medical
condition at last office visit
Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957893
Page 162 of 543
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Oct-02-2020 17:09:53 (UTC-06:00) Central
Time (US & Canada)Subject did not get vaccination 2- PI decision
secondary to SAE and unstable medical
condition at last office visit
Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957894
Page 163 of 543
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aOct-02-2020 17:09:53 (UTC-06:00) Central
Time (US & Canada)Subject did not get vaccination 2- PI decision
secondary to SAE and unstable medical
condition at last office visit
Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957895
Page 164 of 543
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bOct-02-2020 17:09:53 (UTC-06:00) Central
Time (US & Canada)Subject did not get vaccination 2- PI decision
secondary to SAE and unstable medical
condition at last office visit
Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957896
Page 165 of 543
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cOct-02-2020 17:09:53 (UTC-06:00) Central
Time (US & Canada)Subject did not get vaccination 2- PI decision
secondary to SAE and unstable medical
condition at last office visit
Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957897
Page 166 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bNov-20-2020 11:08:42 (UTC-06:00) Central
Time (US & Canada)Care Now Urgent Care visit 11/5 Asymptomatic
tested negative and 11/8 with symptoms and
tested positive
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957898
Page 167 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cNov-20-2020 11:08:52 (UTC-06:00) Central
Time (US & Canada)Care Now Urgent Care visit 11/5 Asymptomatic
tested negative and 11/8 with symptoms and
tested positive
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957899
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Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-13-2020 12:55:26 (UTC-06:00) Central
Time (US & Canada)
FormNov-09-2020 14:52:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957900
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-13-2020 12:55:26 (UTC-06:00) Central
Time (US & Canada)
1Nov-09-2020 14:52:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957901
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Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-13-2020 12:55:26 (UTC-06:00) Central
Time (US & Canada)
2Nov-09-2020 14:52:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957902
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-13-2020 12:55:26 (UTC-06:00) Central
Time (US & Canada)
3Nov-09-2020 14:52:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957903
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Nov-13-2020 12:55:26 (UTC-06:00) Central
Time (US & Canada)
4Nov-09-2020 14:52:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957904
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5Nov-13-2020 12:55:26 (UTC-06:00) Central
Time (US & Canada)
5Nov-09-2020 14:52:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957905
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6Nov-13-2020 12:55:26 (UTC-06:00) Central
Time (US & Canada)
6Nov-09-2020 14:52:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957906
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
7Nov-13-2020 12:55:26 (UTC-06:00) Central
Time (US & Canada)
7Nov-09-2020 14:52:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957907
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
8Nov-13-2020 12:55:26 (UTC-06:00) Central
Time (US & Canada)
8Nov-09-2020 14:52:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957908
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
9Nov-13-2020 12:55:26 (UTC-06:00) Central
Time (US & Canada)
9Nov-09-2020 14:52:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957909
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Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.dNov-20-2020 11:06:57 (UTC-06:00) Central
Time (US & Canada)Care Now Urgent Care visit 11/5 Asymptomatic
tested negative and 11/8 with symptoms and
tested positive
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957910
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-09-2020 15:00:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957911
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-09-2020 15:00:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957912
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-09-2020 15:00:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957913
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-09-2020 15:00:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957914
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Nov-09-2020 15:00:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957915
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5Nov-09-2020 15:00:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957916
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6Nov-09-2020 15:00:03 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957917
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***Confidential***
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Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-13-2020 12:47:32 (UTC-06:00) Central
Time (US & Canada)Covid-19 Positive per urgent care-site attempting
to get the medical records for the testing info
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957918
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-09-2020 15:01:07 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957919
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-09-2020 15:01:07 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957920
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-09-2020 15:01:07 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957921
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-09-2020 15:01:07 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957922
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Nov-09-2020 15:01:07 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957923
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957924
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957925
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957926
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957927
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Nov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957928
Page 197 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957929
Page 198 of 543
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0957930
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Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Subject No: 10831029 Subject Initials: ---
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
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Subject No: 10831029 Subject Initials: ---
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ItemDate User Comment
5.bNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
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Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
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ItemDate User Comment
5.bNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
5.bNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
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Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
5.cNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
5.cNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
5.cNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
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ItemDate User Comment
5.dNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
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ItemDate User Comment
5.dNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
5.dNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 fNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
5 fNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0957950
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 fNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
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FDA-CBER-2021-5683-0957951
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 fNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0957952
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
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FDA-CBER-2021-5683-0957953
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
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FDA-CBER-2021-5683-0957954
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
5.gNov-09-2020 15:01:22 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
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FDA-CBER-2021-5683-0957956
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
FormNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
1Nov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
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FDA-CBER-2021-5683-0957958
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
2Nov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
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FDA-CBER-2021-5683-0957959
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
3Nov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
4Nov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
5.aNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
5.aNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
5.aNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
5.aNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
5.bNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
5.bNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
5.bNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
5.bNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957977
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957980
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 fNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957982
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 fNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 fNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957984
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 fNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957985
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957986
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957987
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957988
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957989
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 hNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957990
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 hNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957991
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 hNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957992
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 hNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957993
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.iNov-09-2020 15:01:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f95\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0957994
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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ItemDate User Comment
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
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Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
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…[truncated]