Document text
Page 1 of 451
***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: 10831050 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
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958276
Page 2 of 451
***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: 10831050 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/5/2020
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958277
Page 3 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Demography
1.Subject ID [10831050]
2.Birth Date: /1941
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0958278
Page 4 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/5/2020
2.Erroneous Visit
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958279
Page 5 of 451
***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: 10831050 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
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958280
Page 6 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/5/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958281
Page 7 of 451
***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: 10831050 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:[penicillin allergy]
Start Date: UNK/UNK/1995
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[sulfa allergy]
Start Date: UNK/UNK/1995
Ongoing: YES
1.cLine/MH Number: [3] Comments
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[iron deficient anemia] Comments
Start Date: UNK/UNK/2015 Comments
Ongoing: YES Comments
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cataracts]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[glaucoma]
Start Date: UNK/UNK/2008
Ongoing: YES
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958282
Page 8 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1 fLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
1.gLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
1 hLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
1.iLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
1.jLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958283
Page 9 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1 kLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
1.lLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
1 mLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
1 nLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
1.oLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958284
Page 10 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.pLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
1.qLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
1 rLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958285
Page 11 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Aug/5/2020
2.Weight: [168.6]
3.Unit: LB
4.Height: [58.0]
5.Unit: in
6.Body Mass Index: [35.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958286
Page 12 of 451
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/5/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958287
Page 13 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/5/2020
2.Randomization Number: [222881]
3.Randomization Group: [ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958288
Page 14 of 451
***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: 10831050 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/5/2020
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 [BP6V3W]
5.bSample ID [BP6V3X]
5.cSample ID [BP6V3Y]
5.dSample ID [BG1VKK]
5.eSample ID [BG1VKL]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958289
Page 15 of 451
***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: 10831050 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/5/2020
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 [BP6V45]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958290
Page 16 of 451
***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: 10831050 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/5/2020 13:49
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
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958291
Page 17 of 451
***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: 10831050 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
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958292
Page 18 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/3/2020
2.Erroneous Visit
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958293
Page 19 of 451
***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: 10831050 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
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958294
Page 20 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958295
Page 21 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958296
Page 22 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958297
Page 23 of 451
***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: 10831050 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:
Sep/3/2020
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 [BPZ1M9]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958298
Page 24 of 451
***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: 10831050 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: Sep/3/2020 16:27
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958299
Page 25 of 451
***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: 10831050 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
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958300
Page 26 of 451
***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: 10831050 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
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958301
Page 27 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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: RIGHT
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
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958302
Page 28 of 451
***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: 10831050 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:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZ1N4]
5.bSample ID [BLCJYS]
5.cSample ID [ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958303
Page 29 of 451
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958304
Page 30 of 451
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 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 [ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958305
Page 31 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958306
Page 32 of 451
***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: 10831050 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 [ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958307
Page 33 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958308
Page 34 of 451
***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: 10831050 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 [ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958309
Page 35 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958310
Page 36 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Aug/28/2020
2.Date of First Symptom Started: Aug/27/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/2/2020
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? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Nasal Discharge]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958311
Page 37 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
1. DELETED Aug/28/2
020 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958312
Page 38 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Aug/28/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: INDETERMINATE
8.Comments/Findings/Details: [COPAN ITALIA ]
9.Trade Name Other, Specify: [FLOQswab ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958313
Page 39 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
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:[Site is not seeing a line 4 to enter as requested. This subject did not do a self swab. The
subject came in for V2 and prior to visit never recorded any covid related symptoms in
diary or to site.]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP6TYF]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958314
Page 40 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 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/28/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP6TYF]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958315
Page 41 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: HEALTH CARE UTILIZATION
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 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: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958316
Page 42 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicabl
e Not Applicabl
e Not Applicabl
e Repeating
Pages
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958317
Page 43 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 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
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958318
Page 44 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS Comments
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO Comments
3.Toxicity Grade: 1 Comments
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958319
Page 45 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958320
Page 46 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 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 Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958321
Page 47 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
1.Not Done Not Done Not Done Not Done Sponsor-Defined Ide
ntifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958322
Page 48 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 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 Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958323
Page 49 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958324
Page 50 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958325
Page 51 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958326
Page 52 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Category for La
b TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958327
Page 53 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 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 Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958328
Page 54 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958329
Page 55 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958330
Page 56 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958331
Page 57 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958332
Page 58 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958333
Page 59 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Date: Vital Signs Details Form Instance
1.Aug/28/2020 Record Identifier: Systolic: Diastolic:
1 Not Done Not Done Repeating Pages
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958334
Page 60 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 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: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: [75]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958335
Page 61 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Date: Vital Signs Details Form Instance
1.Aug/28/2020 Record Identifier: Oxygen Saturation
1 97.0 Repeating Pages
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958336
Page 62 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 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: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958337
Page 63 of 451
***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: 10831050 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
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958338
Page 64 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 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
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958339
Page 65 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applica
ble Repeating
Pages
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958340
Page 66 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 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
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958341
Page 67 of 451
***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: 10831050 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
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958342
Page 68 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 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
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958343
Page 69 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/02/2020Form: 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: 10831050 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
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958344
Page 70 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Oct/02/2020Form: 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: 10831050 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 [BPZ1N4]
5.bSample ID [BLCJYT]
5.cSample ID [BLCJYS]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958345
Page 71 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958346
Page 72 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Unplanned Assessments
1.Assessments
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958347
Page 73 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958348
Page 74 of 451
***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: 10831050 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: [ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958349
Page 75 of 451
***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: 10831050 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:
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958350
Page 76 of 451
***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: 10831050 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 [ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958351
Page 77 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1. DELETED ADVERSE EV
ENT 1 Cough Aug/27/2020
00:00 NO
End Date Time:
Aug/28/2020 00:00
Repeating
Pages
2. DELETED ADVERSE EV
ENT 2 Shortness of breath Aug/27/2020
00:00 NO
End Date Time:
Aug/28/2020 00:00
Repeating
Pages
3. DELETED ADVERSE EV
ENT 3 Nasal Discharge Aug/28/2020
00:00 NO
End Date Time:
Sep/3/2020 00:00
Repeating
Pages
4. ADVERSE EV
ENT 4 Neck Stiffness Aug/29/2020
00:00 NO
End Date Time:
Sep/1/2020 00:00
Repeating
Pages
5. ADVERSE EV
ENT 5 Scrapping -Bilateral L
egs Sep/30/2020 0
0:00 YES Repeating
Pages
6. ADVERSE EV
ENT 6 Rotator Cuff Seperatio
n-Right Sep/1/2020 00
:00 YES Repeating
Pages
7. ADVERSE EV
ENT 7 Fall Sep/1/2020 00
:00 NO
End Date Time:
Sep/1/2020 00:00
Repeating
Pages
8. ADVERSE EV
ENT 8 Fall Sep/30/2020 0
0:00 NO
End Date Time:
Sep/30/2020 00:00
Repeating
Pages
9. ADVERSE EV
ENT 9 Brusing-Bilateral Legs
Sep/30/2020 0
0:00 YES Repeating
Pages
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958352
Page 78 of 451
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Cough]
4.Start Date Time: Aug/27/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/28/2020 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:
[Unrelated illness ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958353
Page 79 of 451
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958354
Page 80 of 451
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Shortness of breath ]
4.Start Date Time: Aug/27/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/28/2020 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:
[Unrelated illness ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958355
Page 81 of 451
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958356
Page 82 of 451
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Nasal Discharge ]
4.Start Date Time: Aug/28/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/3/2020 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:
[Unrelated illness ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958357
Page 83 of 451
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958358
Page 84 of 451
***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: 10831050 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)[Neck Stiffness]
4.Start Date Time: Aug/29/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/1/2020 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:
[ergonomic injury from sleeping wrong]Comments
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958359
Page 85 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958360
Page 86 of 451
***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: 10831050 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)[Scrapping -Bilateral Legs]
4.Start Date Time: Sep/30/2020 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:
[Injury]
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?:RECOVERING/RESOLVING
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958361
Page 87 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958362
Page 88 of 451
***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: 10831050 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)[Rotator Cuff Seperation-Right]
4.Start Date Time: Sep/1/2020 00:00
5.Is the adverse event still ongoing? YES
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:
[Orthopedic]
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?:RECOVERING/RESOLVING
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958363
Page 89 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958364
Page 90 of 451
***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: 10831050 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)[Fall]
4.Start Date Time: Sep/1/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/1/2020 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:
[Injury]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958365
Page 91 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958366
Page 92 of 451
***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: 10831050 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)[Fall]
4.Start Date Time: Sep/30/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/30/2020 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:
[Injury]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958367
Page 93 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958368
Page 94 of 451
***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: 10831050 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)[Brusing-Bilateral Legs]
4.Start Date Time: Sep/30/2020 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:
[Injury]
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?:RECOVERING/RESOLVING
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958369
Page 95 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958370
Page 96 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
1. Repeating
Pages
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958371
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***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: 10831050 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[ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958372
Page 98 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
1. Repeating
Pages
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958373
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***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: 10831050 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: //
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958374
Page 100 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
1. Repeating
Pages
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958375
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***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: 10831050 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?
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958376
Page 102 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958377
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***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: 10831050 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?
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958378
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***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958379
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***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958380
Page 106 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958381
Page 107 of 451
***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: 10831050 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:
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958382
Page 108 of 451
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958383
Page 109 of 451
***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: 10831050 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?
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958384
Page 110 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958385
Page 111 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958386
Page 112 of 451
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958387
Page 113 of 451
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958388
Page 114 of 451
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled 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: 10831050 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 [ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958389
Page 115 of 451
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 10831050 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 [ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958390
Page 116 of 451
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958391
Page 117 of 451
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 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
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958392
Page 118 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/26/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958393
Page 119 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958394
Page 120 of 451
***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: 10831050 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: [ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958395
Page 121 of 451
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958396
Page 122 of 451
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958397
Page 123 of 451
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not Met
Exclusion Criteria Met
2.Description of Exclusion Criterion
Met
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958398
Page 124 of 451
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958399
Page 125 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/2/2020
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958400
Page 126 of 451
***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: 10831050 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
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958401
Page 127 of 451
***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: 10831050 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 15:46:25 (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.
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958402
Page 128 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormAug-06-2020 16:02:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958403
Page 129 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.cAug-07-2020 13:53:12 (UTC-06:00) Central Time
(US & Canada)Permitted Con medications not entered in ecrf but
for clarification and query resoslution subject takes
oral medication for anemia which does not meet Exc
#15
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958404
Page 130 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.cAug-07-2020 13:53:12 (UTC-06:00) Central Time
(US & Canada)Permitted Con medications not entered in ecrf but
for clarification and query resoslution subject takes
oral medication for anemia which does not meet Exc
#15
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958405
Page 131 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.cAug-07-2020 13:53:12 (UTC-06:00) Central Time
(US & Canada)Permitted Con medications not entered in ecrf but
for clarification and query resoslution subject takes
oral medication for anemia which does not meet Exc
#15
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958406
Page 132 of 451
***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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.cAug-07-2020 13:53:12 (UTC-06:00) Central Time
(US & Canada)Permitted Con medications not entered in ecrf but
for clarification and query resoslution subject takes
oral medication for anemia which does not meet Exc
#15
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958407
Page 133 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormSep-03-2020 16:28:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958408
Page 134 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Sep-03-2020 16:28:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958409
Page 135 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Sep-03-2020 16:28:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958410
Page 136 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Sep-03-2020 16:28:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958411
Page 137 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Sep-03-2020 16:28:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958412
Page 138 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5Sep-03-2020 16:28:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958413
Page 139 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6.aSep-03-2020 16:28:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958414
Page 140 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6.aSep-03-2020 16:28:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958415
Page 141 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6.aSep-03-2020 16:28:57 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958416
Page 142 of 451
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Oct-12-2020 12:34:45 (UTC-06:00) Central Time
(US & Canada)Barcodes are listed under the Illnes convalescent
visit
Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958417
Page 143 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormSep-02-2020 12:46:52 (UTC-06:00) Central Time
(US & Canada)Not done performed in office by PI
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958418
Page 144 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormAug-28-2020 17:34:41 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958419
Page 145 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Aug-28-2020 17:34:41 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958420
Page 146 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Aug-28-2020 17:34:41 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958421
Page 147 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Aug-28-2020 17:34:41 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958422
Page 148 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Aug-28-2020 17:34:41 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958423
Page 149 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5Aug-28-2020 17:34:41 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958424
Page 150 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6Aug-28-2020 17:34:41 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958425
Page 151 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormSep-29-2020 14:33:30 (UTC-06:00) Central Time
(US & Canada)
FormSep-18-2020 16:06:02 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958426
Page 152 of 451
***Confidential***
Header Text: c4591001
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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Sep-29-2020 14:33:30 (UTC-06:00) Central Time
(US & Canada)
1Sep-18-2020 16:06:02 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958427
Page 153 of 451
***Confidential***
Header Text: c4591001
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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Sep-29-2020 14:33:30 (UTC-06:00) Central Time
(US & Canada)
2Sep-18-2020 16:06:02 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958428
Page 154 of 451
***Confidential***
Header Text: c4591001
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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Sep-29-2020 14:33:30 (UTC-06:00) Central Time
(US & Canada)
3Sep-18-2020 16:06:02 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958429
Page 155 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormAug-31-2020 16:52:23 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958430
Page 156 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Aug-31-2020 16:52:23 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958431
Page 157 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Aug-31-2020 16:52:23 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958432
Page 158 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Aug-31-2020 16:52:23 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958433
Page 159 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Aug-31-2020 16:52:23 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958434
Page 160 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958435
Page 161 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Aug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958436
Page 162 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Aug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958437
Page 163 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Aug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958438
Page 164 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Aug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958439
Page 165 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958440
Page 166 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958441
Page 167 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958442
Page 168 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958443
Page 169 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958444
Page 170 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958445
Page 171 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958446
Page 172 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958447
Page 173 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958448
Page 174 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958449
Page 175 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958450
Page 176 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958451
Page 177 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958452
Page 178 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958453
Page 179 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958454
Page 180 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958455
Page 181 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958456
Page 182 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958457
Page 183 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958458
Page 184 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958459
Page 185 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 fAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958460
Page 186 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 fAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958461
Page 187 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 fAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958462
Page 188 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 fAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958463
Page 189 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958464
Page 190 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958465
Page 191 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958466
Page 192 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gAug-31-2020 16:51:59 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958467
Page 193 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958468
Page 194 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Aug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958469
Page 195 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Aug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958470
Page 196 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Aug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958471
Page 197 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Aug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958472
Page 198 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958473
Page 199 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958474
Page 200 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958475
Page 201 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958476
Page 202 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958477
Page 203 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958478
Page 204 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958479
Page 205 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958480
Page 206 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958481
Page 207 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958482
Page 208 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958483
Page 209 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958484
Page 210 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958485
Page 211 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958486
Page 212 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958487
Page 213 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958488
Page 214 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958489
Page 215 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958490
Page 216 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958491
Page 217 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958492
Page 218 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 fAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958493
Page 219 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 fAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958494
Page 220 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 fAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958495
Page 221 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 fAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958496
Page 222 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958497
Page 223 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958498
Page 224 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958499
Page 225 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958500
Page 226 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 hAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958501
Page 227 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 hAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958502
Page 228 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 hAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958503
Page 229 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5 hAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958504
Page 230 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.iAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958505
Page 231 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.iAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958506
Page 232 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.iAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958507
Page 233 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.iAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958508
Page 234 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.jAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958509
Page 235 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.jAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958510
Page 236 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.jAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958511
Page 237 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: 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: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.jAug-31-2020 16:51:40 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958512
Page 238 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.aAug-31-2020 16:50:04 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
2.aAug-31-2020 16:48:49 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958513
Page 239 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.aAug-31-2020 16:50:23 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958514
Page 240 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.aAug-31-2020 16:50:36 (UTC-06:00) Central Time
(US & Canada)Instructed by CRA to follow V2 visit and collection
further vitals was not a required assessment
Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958515
Page 241 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormAug-31-2020 16:39:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958516
Page 242 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Aug-31-2020 16:39:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958517
Page 243 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Aug-31-2020 16:39:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958518
Page 244 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Aug-31-2020 16:39:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958519
Page 245 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormAug-31-2020 16:39:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958520
Page 246 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Aug-31-2020 16:39:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958521
Page 247 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Aug-31-2020 16:39:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958522
Page 248 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Aug-31-2020 16:39:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958523
Page 249 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Aug-31-2020 16:39:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958524
Page 250 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5Aug-31-2020 16:39:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958525
Page 251 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6Aug-31-2020 16:39:38 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958526
Page 252 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormAug-31-2020 16:39:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
FormAug-31-2020 16:38:50 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958527
Page 253 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Aug-31-2020 16:39:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Aug-31-2020 16:38:50 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958528
Page 254 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Aug-31-2020 16:39:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Aug-31-2020 16:38:50 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958529
Page 255 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Aug-31-2020 16:39:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Aug-31-2020 16:38:50 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958530
Page 256 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Aug/28/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Aug-31-2020 16:39:27 (UTC-06:00) Central Time
(US & Canada)Not Applicable
4Aug-31-2020 16:38:50 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958531
Page 257 of 451
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
9Sep-10-2020 10:04:02 (UTC-06:00) Central Time
(US & Canada)09SEP2020 PI readvised on "Related" AE and with
discussion from work up CRC and PI ruled to Not
related and progress notes and AE source will have
late entry updates
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0958532
Page 258 of 451
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
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 15:46:25 (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.
N/A Feb-10-2021 14:53:39 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laurence Chu Approved Nov-17-2020 10:24:58 (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.
N/A Nov-16-2020 17:08:09 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laurence Chu Approved Nov-06-2020 14:30:20 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0958533
Page 259 of 451
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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.
N/A Nov-06-2020 10:48:08 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laurence Chu Approved Oct-21-2020 08:17:11 (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.
N/A Oct-16-2020 09:21:11 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laurence Chu Approved Oct-12-2020 12:43:05 (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.
N/A Oct-12-2020 12:34:45 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0958534
Page 260 of 451
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Affidavit:
N/A
Laurence Chu Approved Oct-09-2020 16:50:05 (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.
N/A Oct-02-2020 17:15:26 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laurence Chu Approved Oct-01-2020 17:46:48 (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.
N/A Sep-29-2020 14:33:30 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laurence Chu Approved Sep-24-2020 11:29:04 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0958535
Page 261 of 451
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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.
N/A Sep-23-2020 15:56:20 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laurence Chu Approved Sep-21-2020 12:18:42 (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.
N/A Sep-18-2020 16:05:44 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laurence Chu Approved Sep-14-2020 19:22:11 (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.
N/A Sep-14-2020 16:29:31 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0958536
Page 262 of 451
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Affidavit:
N/A
Laurence Chu Approved Sep-14-2020 12:31:40 (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.
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0958537
Page 263 of 451
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-05-2020 14:59:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-05-2020 14:59:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0958538
Page 264 of 451
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-05-2020 15:00:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/5/2020Initial Entry
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0958539
Page 265 of 451
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831050 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-05-2020 14:59:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10831050Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-05-2020 14:59:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1941Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-05-2020 15:01:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-05-2020 15:01:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-05-2020 15:01:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3f93\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0958540
Page 266 of 451
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked,
…[truncated]