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: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960364
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: 10831173 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/27/2020
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960365
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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Demography
1.Subject ID [10831173]
2.Birth Date: /1959
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0960366
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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960367
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: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960368
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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960369
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: 10831173 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/1987
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic Rhinitis-Seasonal]
Start Date: UNK/UNK/1965
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism]
Start Date: UNK/UNK/1972
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/2010
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Attention deficit hyperactivity disorder]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960370
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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: UNK/UNK/2010
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: UNK/UNK/2010
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Nodular Prostate]
Start Date: UNK/UNK/2019
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Testicular Hypofunction]
Start Date: UNK/UNK/2013
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Testicular Hypogonadism]
Start Date: UNK/UNK/2009
Ongoing: YES
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960371
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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Erectile Dysfunction]
Start Date: UNK/UNK/2011
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Benign prostatic hyperplasia]
Start Date: UNK/UNK/2009
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Elevated Prostate-Specific Antigen]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960372
Page 10 of 451
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
2.Weight: [192.7]
3.Unit: LB
4.Height: [70.0]
5.Unit: in
6.Body Mass Index: [27.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960373
Page 11 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/27/2020
2.Randomization Number: [242518]
3.Randomization Group: [ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960374
Page 12 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: 10831173 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/27/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZ1KB]
5.bSample ID [BPZ1KC]
5.cSample ID [BPZ1KD]
5.dSample ID [BG1VVD]
5.eSample ID [BG1VVF]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960375
Page 13 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: 10831173 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/27/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP6TY9]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960376
Page 14 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: 10831173 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/27/2020 15:36
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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960377
Page 15 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960378
Page 16 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960379
Page 17 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Temperature: Not Applicable
[ ]Comments
Unit: Not Applicable Comments
Temperature Location: Not Applicable Comments
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960380
Page 18 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
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.Sample ID Not Applicable
[ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960381
Page 19 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Sep/15/2020
Reason(s) for Temporary Delay of Vaccination
RECENT NON-STUDY VACCINATION
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location:
6.Body Side: Not Done Comments
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?Not Done Comments
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960382
Page 20 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, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/23/2020
2.Erroneous Visit
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960383
Page 21 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, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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 Comments
2.Sample Type SERUM Comments
3.Sample Collected? NO Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[SAMP TRK SERUM found in the Convalescent Visit 23NOV2020] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960384
Page 22 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960385
Page 23 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: 10831173 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 [ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960386
Page 24 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960387
Page 25 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: 10831173 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 [ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960388
Page 26 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960389
Page 27 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: 10831173 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 [ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960390
Page 28 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960391
Page 29 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/26/2020
2.Date of First Symptom Started: Oct/22/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/1/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960392
Page 30 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
5.aSymptoms - Other Text: [General Body Aches]
5.bSymptoms - Other Text: [Headaches]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960393
Page 31 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Date of Co
llectionSpecimen Typ
eSpecimen Collect
ion LocationAssay Code and Description Device TypeForm Instan
ce
1.Oct/23/202
0 SWABBED M
ATERIAL NASOPHARYNX
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960394
Page 32 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/23/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: ABBOTT DIAGNOSTICS ID NOW COVID-19 Comments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [ ] Comments
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960395
Page 33 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/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 [CV47284]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960396
Page 34 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960397
Page 35 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[2]Comments
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ] Comments
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO Comments
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960398
Page 36 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicabl
e Not Applicabl
e Not Applicab
le Repeating
Pages
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960399
Page 37 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960400
Page 38 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960401
Page 39 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: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960402
Page 40 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960403
Page 41 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960404
Page 42 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960405
Page 43 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960406
Page 44 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960407
Page 45 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960408
Page 46 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Category for L
ab 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960409
Page 47 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960410
Page 48 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960411
Page 49 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960412
Page 50 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960413
Page 51 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960414
Page 52 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960415
Page 53 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960416
Page 54 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960417
Page 55 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960418
Page 56 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960419
Page 57 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: 10831173 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 Done Not Done Not Done Repeating Pages
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960420
Page 58 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 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 Done
//Comments
2.Arterial Blood Gases PaO2 (mmHg): Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960421
Page 59 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applic
able Repeating
Pages
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960422
Page 60 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960423
Page 61 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: 10831173 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 Done Not Done Not Done Not Done Repeating Pages
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960424
Page 62 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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 Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960425
Page 63 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/23/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/23/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960426
Page 64 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/23/2020Form: 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: 10831173 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:
Nov/23/2020
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 [BLBR7F]
5.bSample ID [BLBR7G]
5.cSample ID [BRCJ5N]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960427
Page 65 of 451
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960428
Page 66 of 451
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/26/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Unplanned Assessments
1.Assessments Not Applicable Comments
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960429
Page 67 of 451
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/26/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Contact Outcome
1.Contact Type: Not Applicable Comments
2.Was contact made? Not Applicable Comments
3.Comments: Not Applicable
[ ]Comments
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960430
Page 68 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/2/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT Comments
4.Specify Status: [ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960431
Page 69 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: 10831173 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: [ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960432
Page 70 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: 10831173 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:
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960433
Page 71 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: 10831173 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 [ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960434
Page 72 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
1. DELETED ADVERSE E
VENT 1 Prostate Nodule Oct/9/2020 1
7:53 YES Repeating
Pages
2. DELETED ADVERSE E
VENT 2 Elevated Prostate-speci
fic antigen Sep/1/2020 0
0:00 YES Repeating
Pages
3. ADVERSE E
VENT 3 Tooth Infection Oct/12/2020
00:00 NO
End Date Time:
Nov/3/2020 00:00
Repeating
Pages
4. ADVERSE E
VENT 4 Prostate Cancer Nov/2/2020 0
0:00 YES Repeating
Pages
5. ADVERSE E
VENT 5 Tooth Extraction Nov/20/2020
00:00 NO
End Date Time:
Nov/20/2020 00:00
Repeating
Pages
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960435
Page 73 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
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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)[Prostate Nodule ]
4.Start Date Time: Oct/9/2020 17:53
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:
[Mass of Uncertain Pathology ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960436
Page 74 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
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960437
Page 75 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
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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)[Elevated Prostate-specific antigen ]
4.Start Date Time: Sep/1/2020 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:
[Prostate Vein ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960438
Page 76 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
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960439
Page 77 of 451
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Tooth Infection]
4.Start Date Time: Oct/12/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/3/2020 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:
[Dental Caries]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960440
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, Frozen
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960441
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, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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)[Prostate Cancer]
4.Start Date Time: Nov/2/2020 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:
[Cancer]
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960442
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, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960443
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, Frozen
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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)[Tooth Extraction]
4.Start Date Time: Nov/20/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/20/2020 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:
[Dental Caries]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960444
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, Frozen
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960445
Page 83 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960446
Page 84 of 451
***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: 10831173 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[ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960447
Page 85 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart Dat
eForm Instanc
e
1.1 VACCINATIONS NO Tetanus Vaccine
Sep/10/20
20 Repeating
Pages
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960448
Page 86 of 451
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[Tetanus Vaccine]
5.Date: Sep/10/2020
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960449
Page 87 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960450
Page 88 of 451
***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: 10831173 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?
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960451
Page 89 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: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960452
Page 90 of 451
***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: 10831173 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?
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960453
Page 91 of 451
***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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960454
Page 92 of 451
***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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960455
Page 93 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960456
Page 94 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: 10831173 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:
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960457
Page 95 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: 10831173 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?
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960458
Page 96 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960459
Page 97 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960460
Page 98 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960461
Page 99 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960462
Page 100 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: 10831173 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 [ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960463
Page 101 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: 10831173 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 [ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960464
Page 102 of 451
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960465
Page 103 of 451
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 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 other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960466
Page 104 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/13/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960467
Page 105 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960468
Page 106 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: 10831173 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: [ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960469
Page 107 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960470
Page 108 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960471
Page 109 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: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960472
Page 110 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: 10831173 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: [ ]
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960473
Page 111 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/2/2020
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960474
Page 112 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: 10831173 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
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960475
Page 113 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: 10831173 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-12-2021 09:05:35 (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.
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960476
Page 114 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormAug-28-2020 11:09:31 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960477
Page 115 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-17-2020 09:36:43 (UTC-06:00) Central Time
(US & Canada)subject was discontinued from receiving Vax 2
FormNov-17-2020 09:36:32 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960478
Page 116 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-17-2020 09:36:32 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960479
Page 117 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.aNov-17-2020 09:36:32 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960480
Page 118 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.aNov-17-2020 09:36:32 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960481
Page 119 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.aNov-17-2020 09:36:32 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960482
Page 120 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-17-2020 09:36:10 (UTC-06:00) Central Time
(US & Canada)subject was discontinued from receiving Vax 2
FormNov-17-2020 09:35:44 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960483
Page 121 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-17-2020 09:35:44 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960484
Page 122 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-17-2020 09:35:44 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960485
Page 123 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-17-2020 09:35:44 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960486
Page 124 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Nov-17-2020 09:35:44 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960487
Page 125 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-17-2020 09:37:16 (UTC-06:00) Central Time
(US & Canada)subject was discontinued from receiving Vax 2
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960488
Page 126 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Nov-17-2020 14:00:54 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960489
Page 127 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6Nov-17-2020 14:01:07 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960490
Page 128 of 451
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
11Nov-17-2020 14:01:15 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960491
Page 129 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, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-23-2020 15:15:31 (UTC-06:00) Central Time
(US & Canada)
FormNov-04-2020 12:39:10 (UTC-06:00) Central Time
(US & Canada)Visit entered in error
Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960492
Page 130 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, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-23-2020 15:15:31 (UTC-06:00) Central Time
(US & Canada)
1Nov-04-2020 12:39:10 (UTC-06:00) Central Time
(US & Canada)Visit entered in error
Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960493
Page 131 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, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-23-2020 15:15:31 (UTC-06:00) Central Time
(US & Canada)
2Nov-04-2020 12:39:10 (UTC-06:00) Central Time
(US & Canada)Visit entered in error
Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960494
Page 132 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, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-23-2020 15:15:31 (UTC-06:00) Central Time
(US & Canada)
3Nov-04-2020 12:39:10 (UTC-06:00) Central Time
(US & Canada)Visit entered in error
Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960495
Page 133 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, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Nov-23-2020 15:15:31 (UTC-06:00) Central Time
(US & Canada)
4Nov-04-2020 12:39:10 (UTC-06:00) Central Time
(US & Canada)Visit entered in error
Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960496
Page 134 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-05-2020 13:59:38 (UTC-06:00) Central Time
(US & Canada)
FormNov-03-2020 10:07:53 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960497
Page 135 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-05-2020 13:59:38 (UTC-06:00) Central Time
(US & Canada)
1Nov-03-2020 10:07:53 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960498
Page 136 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-05-2020 13:59:38 (UTC-06:00) Central Time
(US & Canada)
2Nov-03-2020 10:07:53 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960499
Page 137 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-05-2020 13:59:38 (UTC-06:00) Central Time
(US & Canada)
3Nov-03-2020 10:07:53 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960500
Page 138 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Nov-05-2020 13:59:38 (UTC-06:00) Central Time
(US & Canada)
4Nov-03-2020 10:07:53 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960501
Page 139 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5Nov-05-2020 13:59:38 (UTC-06:00) Central Time
(US & Canada)
5Nov-03-2020 10:07:53 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960502
Page 140 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6Nov-05-2020 13:59:38 (UTC-06:00) Central Time
(US & Canada)
6Nov-03-2020 10:07:53 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960503
Page 141 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
7Nov-05-2020 13:59:38 (UTC-06:00) Central Time
(US & Canada)
7Nov-03-2020 10:07:53 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960504
Page 142 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
8Nov-05-2020 13:59:38 (UTC-06:00) Central Time
(US & Canada)
8Nov-03-2020 10:07:53 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960505
Page 143 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
9Nov-05-2020 13:59:38 (UTC-06:00) Central Time
(US & Canada)
9Nov-03-2020 10:07:53 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960506
Page 144 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-03-2020 10:08:05 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960507
Page 145 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-03-2020 10:08:05 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960508
Page 146 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-03-2020 10:08:05 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960509
Page 147 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-03-2020 10:08:05 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960510
Page 148 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Nov-03-2020 10:08:05 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960511
Page 149 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-05-2020 09:30:34 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
FormNov-04-2020 12:31:56 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
Not Done
FormNov-04-2020 11:17:41 (UTC-06:00) Central Time
(US & Canada)
FormNov-03-2020 10:14:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960512
Page 150 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.aNov-05-2020 09:30:34 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
1.aNov-04-2020 12:31:56 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
Not Done
1.aNov-04-2020 11:17:41 (UTC-06:00) Central Time
(US & Canada)
1.aNov-03-2020 10:14:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960513
Page 151 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.bNov-05-2020 09:30:34 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
1.bNov-04-2020 12:31:56 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
Not Done
1.bNov-04-2020 11:17:41 (UTC-06:00) Central Time
(US & Canada)
1.bNov-03-2020 10:14:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960514
Page 152 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.cNov-05-2020 09:30:34 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
1.cNov-04-2020 12:31:56 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
Not Done
1.cNov-04-2020 11:17:41 (UTC-06:00) Central Time
(US & Canada)
1.cNov-03-2020 10:14:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960515
Page 153 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.dNov-05-2020 09:30:34 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
1.dNov-04-2020 12:31:56 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
Not Done
1.dNov-04-2020 11:17:41 (UTC-06:00) Central Time
(US & Canada)
1.dNov-03-2020 10:14:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960516
Page 154 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.eNov-05-2020 09:30:34 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
1.eNov-04-2020 12:31:56 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
Not Done
1.eNov-04-2020 11:17:41 (UTC-06:00) Central Time
(US & Canada)
1.eNov-03-2020 10:14:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960517
Page 155 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.fNov-05-2020 09:30:34 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
1.fNov-04-2020 12:31:56 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
Not Done
1.fNov-04-2020 11:17:41 (UTC-06:00) Central Time
(US & Canada)
1.fNov-03-2020 10:14:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960518
Page 156 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-05-2020 09:30:34 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
2Nov-04-2020 12:31:56 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
Not Done
2Nov-04-2020 11:17:41 (UTC-06:00) Central Time
(US & Canada)
2Nov-03-2020 10:14:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960519
Page 157 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-05-2020 09:30:34 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
3Nov-04-2020 12:31:56 (UTC-06:00) Central Time
(US & Canada)Thank you for response. Please add form level
comment of NOT DONE in COVID TEST,
HEALTHCARE, ILL POTEN, SWAB PFE forms.
Not Done
3Nov-04-2020 11:17:41 (UTC-06:00) Central Time
(US & Canada)
3Nov-03-2020 10:14:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960520
Page 158 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-03-2020 10:10:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960521
Page 159 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-03-2020 10:10:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960522
Page 160 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-03-2020 10:10:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960523
Page 161 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-03-2020 10:10:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Nov-03-2020 10:10:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960524
Page 162 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Nov-03-2020 10:10:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960525
Page 163 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5Nov-03-2020 10:10:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960526
Page 164 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6Nov-03-2020 10:10:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960527
Page 165 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-05-2020 09:30:08 (UTC-06:00) Central Time
(US & Canada)
FormNov-04-2020 12:31:26 (UTC-06:00) Central Time
(US & Canada)Not Done
Not Done
FormNov-04-2020 10:55:52 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960528
Page 166 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-05-2020 09:30:08 (UTC-06:00) Central Time
(US & Canada)
1Nov-04-2020 12:31:26 (UTC-06:00) Central Time
(US & Canada)Not Done
Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960529
Page 167 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-05-2020 09:30:08 (UTC-06:00) Central Time
(US & Canada)
2Nov-04-2020 12:31:26 (UTC-06:00) Central Time
(US & Canada)Not Done
Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960530
Page 168 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-05-2020 09:30:08 (UTC-06:00) Central Time
(US & Canada)
3Nov-04-2020 12:31:26 (UTC-06:00) Central Time
(US & Canada)Not Done
Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960531
Page 169 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-03-2020 10:14:57 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960532
Page 170 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-03-2020 10:14:57 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960533
Page 171 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-03-2020 10:14:57 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960534
Page 172 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-03-2020 10:14:57 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960535
Page 173 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Nov-03-2020 10:14:57 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960536
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960537
Page 175 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960538
Page 176 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960539
Page 177 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960540
Page 178 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Nov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960541
Page 179 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960542
Page 180 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960543
Page 181 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960544
Page 182 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960545
Page 183 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960546
Page 184 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960547
Page 185 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960548
Page 186 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960549
Page 187 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960550
Page 188 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960551
Page 189 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960552
Page 190 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960553
Page 191 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960554
Page 192 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960555
Page 193 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960556
Page 194 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960557
Page 195 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960558
Page 196 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960559
Page 197 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960560
Page 198 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960561
Page 199 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.fNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960562
Page 200 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.fNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960563
Page 201 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.fNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960564
Page 202 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.fNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960565
Page 203 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960566
Page 204 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960567
Page 205 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960568
Page 206 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gNov-03-2020 10:15:20 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960569
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960570
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960571
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960572
Page 210 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960573
Page 211 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Nov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960574
Page 212 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960575
Page 213 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960576
Page 214 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960577
Page 215 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.aNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960578
Page 216 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960579
Page 217 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960580
Page 218 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960581
Page 219 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.bNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960582
Page 220 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960583
Page 221 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960584
Page 222 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960585
Page 223 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.cNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960586
Page 224 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960587
Page 225 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960588
Page 226 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960589
Page 227 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.dNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960590
Page 228 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960591
Page 229 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960592
Page 230 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960593
Page 231 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.eNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960594
Page 232 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.fNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960595
Page 233 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.fNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960596
Page 234 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.fNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960597
Page 235 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.fNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960598
Page 236 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960599
Page 237 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960600
Page 238 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960601
Page 239 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.gNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960602
Page 240 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.hNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960603
Page 241 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.hNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960604
Page 242 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.hNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960605
Page 243 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.hNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960606
Page 244 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.iNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960607
Page 245 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.iNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960608
Page 246 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.iNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960609
Page 247 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.iNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960610
Page 248 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.jNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960611
Page 249 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.jNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960612
Page 250 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.jNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960613
Page 251 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5.jNov-03-2020 10:15:33 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960614
Page 252 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-03-2020 10:16:01 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960615
Page 253 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-03-2020 10:16:01 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960616
Page 254 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.aNov-03-2020 10:16:01 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960617
Page 255 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.aNov-03-2020 10:16:01 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960618
Page 256 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.aNov-03-2020 10:16:01 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960619
Page 257 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.aNov-03-2020 10:16:01 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960620
Page 258 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-03-2020 10:16:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960621
Page 259 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-03-2020 10:16:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960622
Page 260 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2.aNov-03-2020 10:16:12 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960623
Page 261 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-03-2020 10:16:22 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960624
Page 262 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-03-2020 10:16:22 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960625
Page 263 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-03-2020 10:16:22 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960626
Page 264 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-03-2020 10:16:22 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960627
Page 265 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-03-2020 10:16:32 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960628
Page 266 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-03-2020 10:16:32 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960629
Page 267 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-03-2020 10:16:32 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960630
Page 268 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-03-2020 10:16:32 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960631
Page 269 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Nov-03-2020 10:16:32 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960632
Page 270 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5Nov-03-2020 10:16:32 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960633
Page 271 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6Nov-03-2020 10:16:32 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960634
Page 272 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-03-2020 10:16:57 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960635
Page 273 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-03-2020 10:16:57 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960636
Page 274 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-03-2020 10:16:57 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960637
Page 275 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-03-2020 10:16:57 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960638
Page 276 of 451
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/26/2020Form: 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Nov-03-2020 10:16:57 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960639
Page 277 of 451
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED VISIT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-05-2020 09:51:59 (UTC-06:00) Central Time
(US & Canada)Per CRA and DM guidance telehealth moved to
Covid Illness Visit
Not Applicable
1Nov-05-2020 09:45:43 (UTC-06:00) Central Time
(US & Canada)Per CRA and DM guidance telehealth moved to
Covid Illness Visit
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960640
Page 278 of 451
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Oct/26/2020Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-03-2020 10:22:02 (UTC-06:00) Central Time
(US & Canada)visit moved to Pot Cov Ill as instructed
Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960641
Page 279 of 451
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Nov-03-2020 10:22:02 (UTC-06:00) Central Time
(US & Canada)visit moved to Pot Cov Ill as instructed
Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960642
Page 280 of 451
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Nov-03-2020 10:22:02 (UTC-06:00) Central Time
(US & Canada)visit moved to Pot Cov Ill as instructed
Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960643
Page 281 of 451
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-03-2020 10:22:02 (UTC-06:00) Central Time
(US & Canada)visit moved to Pot Cov Ill as instructed
Not Applicable
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960644
Page 282 of 451
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormNov-17-2020 14:02:39 (UTC-06:00) Central Time
(US & Canada)discontinued from treatment
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960645
Page 283 of 451
***Confidential***
Header Text: c4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Nov-16-2020 15:50:43 (UTC-06:00) Central Time
(US & Canada)New Diagnosis of Prostate Cancer
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960646
Page 284 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: 10831173 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-12-2021 09:05:35 (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 Jan-28-2021 17:01:03 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laurence Chu Approved Jan-20-2021 18:17:45 (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-23-2020 14:55:09 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laurence Chu Approved Nov-17-2020 16:22:49 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0960647
Page 285 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: 10831173 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-17-2020 14:00:54 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laurence Chu Approved Nov-17-2020 10:28:39 (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-17-2020 09:33:46 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laurence Chu Approved Nov-16-2020 17:18:48 (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.
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0960648
Page 286 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: 10831173 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-28-2020 11:08:00
(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-28-2020 11:08:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960649
Page 287 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020 11:09:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-28-2020 11:09:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date Informed
Consent Obtained is
not the same as the
Date of Visit. Please
correct as necessary.
Aug-28-2020 11:08:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/27/2020Initial Entry
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960650
Page 288 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: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020 11:07:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10831173Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020 11:07:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1959Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020 11:09:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-28-2020 11:09:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020 11:09:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960651
Page 289 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, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-28-2020 11:09:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Transcription Error
Aug-28-2020 11:09:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
090177e196ae3f96\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0960652
Page 290 of 451
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1083 Site Name: (1083) Benchmark Research
Subject No: 10831173 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User
…[truncated]