125742 S1 M5 CRF c4591001 1161 11611020

Document text

Page 1 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842342
Page 2 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/3/2020
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842343
Page 3 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11611020]
2.Birth Date: /1992
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:
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842344
Page 4 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/3/2020
2.Erroneous Visit
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842345
Page 5 of 734
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for inclusion
in the study
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance
with the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN04A00
Exclusion Criteria
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842346
Page 6 of 734
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency,
as determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX08A00
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842347
Page 7 of 734
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would,
in the opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX11A00
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX14A01
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842348
Page 8 of 734
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing
lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX21A01
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842349
Page 9 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842350
Page 10 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Codeine Allergy]
Start Date: UNK/UNK/1997
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Heartburn]
Start Date: UNK/UNK/2008
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Back pain radiculopathy to thighs, bilateral]
Start Date: Mar/12/2020
Ongoing: YES
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842351
Page 11 of 734
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Aug/3/2020
2.Weight: [89.4]
3.Unit: kg
4.Height: [170.0]
5.Unit: cm
6.Body Mass Index: [30.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.9]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842352
Page 12 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/3/2020
2.Randomization Number: [41392]
3.Randomization Group: [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842353
Page 13 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/3/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPLL62]
5.bSample ID [BPLL63]
5.cSample ID [BPLL64]
5.dSample ID [BPLL65]
5.eSample ID [BP3D44]
5.fSample ID [BP3D45]
5.gSample ID [BP3D46]
5.hSample ID [BP3D47]
5.iSample ID [BP3D48]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842354
Page 14 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/3/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3D8J]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842355
Page 15 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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/3/2020 13:54
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
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842356
Page 16 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842357
Page 17 of 734
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/23/2020
2.Erroneous Visit
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842358
Page 18 of 734
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/11/2020
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/10/2020
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842359
Page 19 of 734
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/11/2020
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842360
Page 20 of 734
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Nov/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842361
Page 21 of 734
***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, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
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 [BP3DC4]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842362
Page 22 of 734
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: Nov/23/2020 11:00
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
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842363
Page 23 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/22/2020
2.Erroneous Visit
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842364
Page 24 of 734
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Dec/3/2020
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842365
Page 25 of 734
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842366
Page 26 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/22/2020
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 [BPLLCL]
5.bSample ID [BPLLCK]
5.cSample ID [BP3DD3]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842367
Page 27 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842368
Page 28 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842369
Page 29 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842370
Page 30 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842371
Page 31 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842372
Page 32 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842373
Page 33 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/11/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842374
Page 34 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Aug/11/2020
2.Date of First Symptom Started: Aug/5/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Aug/8/2020
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? YES
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842375
Page 35 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
5.aSymptoms - Other Text: [nausea]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842376
Page 36 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Collect
ionSpecimen T
ypeSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Type Form Instance
 1.Not Applicable  Not Applicab
le Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842377
Page 37 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842378
Page 38 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[confirmed. received sample late]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RW79121]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842379
Page 39 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[subject did self swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842380
Page 40 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: HEALTH CARE UTILIZATION
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842381
Page 41 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842382
Page 42 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842383
Page 43 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842384
Page 44 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842385
Page 45 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842386
Page 46 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842387
Page 47 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842388
Page 48 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842389
Page 49 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842390
Page 50 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842391
Page 51 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842392
Page 52 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842393
Page 53 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842394
Page 54 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842395
Page 55 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842396
Page 56 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842397
Page 57 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842398
Page 58 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842399
Page 59 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842400
Page 60 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020 Comments
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842401
Page 61 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Not Applicable
//Comments
2.Date of First Symptom Started: Not Applicable
//Comments
3.Symptoms Ongoing? Not Applicable Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? Not Applicable Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? Not Applicable Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? Not Applicable Comments
4.dSymptoms: CHILLS
Was symptom present? Not Applicable Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? Not Applicable Comments
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? Not Applicable Comments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842402
Page 62 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? Not Applicable Comments
4.hSymptoms: DIARRHEA
Was symptom present? Not Applicable Comments
4.iSymptoms: VOMITING
Was symptom present? Not Applicable Comments
Symptoms - Other
5.aSymptoms - Other Text: Not Applicable
[ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842403
Page 63 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.          Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842404
Page 64 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Microbiology Specimen
1.Actual Date of Collection: //
2.Specimen Type:
3.Specimen Collection Location:
4.Assay Code and Description:
5.Device Type:
6.Trade Name:
7.Test Result:
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842405
Page 65 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: Not Applicable Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: Not Applicable Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: Not Applicable Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: Not Applicable Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: Not Applicable Comments
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: Not Applicable Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: Not Applicable
[ ]Comments
Health Care Utilization
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842406
Page 66 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
3.Has the subject been hospitalized
due to potential COVID-19 illness?Not Applicable Comments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842407
Page 67 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842408
Page 68 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842409
Page 69 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842410
Page 70 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842411
Page 71 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842412
Page 72 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842413
Page 73 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842414
Page 74 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842415
Page 75 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842416
Page 76 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842417
Page 77 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842418
Page 78 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842419
Page 79 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842420
Page 80 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842421
Page 81 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842422
Page 82 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842423
Page 83 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842424
Page 84 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842425
Page 85 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/21/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842426
Page 86 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/21/2020
2.Date of First Symptom Started: Oct/19/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/21/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842427
Page 87 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
5.aSymptoms - Other Text: [headache]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842428
Page 88 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842429
Page 89 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842430
Page 90 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[subject did not perform self swab within 4 days of symptom resolution.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842431
Page 91 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[subject to complete self swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842432
Page 92 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842433
Page 93 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842434
Page 94 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842435
Page 95 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842436
Page 96 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842437
Page 97 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842438
Page 98 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842439
Page 99 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842440
Page 100 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842441
Page 101 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842442
Page 102 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842443
Page 103 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842444
Page 104 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842445
Page 105 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842446
Page 106 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842447
Page 107 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842448
Page 108 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842449
Page 109 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842450
Page 110 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842451
Page 111 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842452
Page 112 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/10/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_D
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842453
Page 113 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/10/2020
2.Date of First Symptom Started: Nov/7/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/14/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842454
Page 114 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842455
Page 115 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842456
Page 116 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842457
Page 117 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Subject swabbed at site]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842458
Page 118 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/10/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3DB9]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842459
Page 119 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842460
Page 120 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842461
Page 121 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842462
Page 122 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842463
Page 123 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842464
Page 124 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842465
Page 125 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842466
Page 126 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842467
Page 127 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842468
Page 128 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842469
Page 129 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842470
Page 130 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842471
Page 131 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842472
Page 132 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842473
Page 133 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842474
Page 134 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842475
Page 135 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842476
Page 136 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842477
Page 137 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 4 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842478
Page 138 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842479
Page 139 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/19/2020
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_E
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842480
Page 140 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Not Applicable
//Comments
2.Date of First Symptom Started: Not Applicable
//Comments
3.Symptoms Ongoing? Not Applicable Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? Not Applicable Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? Not Applicable Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? Not Applicable Comments
4.dSymptoms: CHILLS
Was symptom present? Not Applicable Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? Not Applicable Comments
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? Not Applicable Comments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842481
Page 141 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? Not Applicable Comments
4.hSymptoms: DIARRHEA
Was symptom present? Not Applicable Comments
4.iSymptoms: VOMITING
Was symptom present? Not Applicable Comments
Symptoms - Other
5.Symptoms - Other Text: Not Applicable
[ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842482
Page 142 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 5 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Collect
ionSpecimen T
ypeSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Type Form Instance
 1.Not Applicable  Not Applicab
le Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842483
Page 143 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842484
Page 144 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
[ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842485
Page 145 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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.aSample ID Not Applicable
[ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842486
Page 146 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: Not Applicable Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: Not Applicable Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: Not Applicable Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: Not Applicable Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: Not Applicable Comments
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: Not Applicable Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: Not Applicable
[ ]Comments
Health Care Utilization
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842487
Page 147 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
3.Has the subject been hospitalized
due to potential COVID-19 illness?Not Applicable Comments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842488
Page 148 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 5 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842489
Page 149 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842490
Page 150 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Was a diagnosis obtained for
Potential COVID-19 Illness?Not Applicable Comments
3.Toxicity Grade: Not Applicable Comments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842491
Page 151 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 5 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842492
Page 152 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842493
Page 153 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 5 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable
 Not Appli
cable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842494
Page 154 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842495
Page 155 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842496
Page 156 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842497
Page 157 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842498
Page 158 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 5 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842499
Page 159 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842500
Page 160 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842501
Page 161 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842502
Page 162 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842503
Page 163 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842504
Page 164 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842505
Page 165 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 5 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842506
Page 166 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842507
Page 167 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 5 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842508
Page 168 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842509
Page 169 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 5 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842510
Page 170 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842511
Page 171 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 5 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842512
Page 172 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842513
Page 173 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 5 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842514
Page 174 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842515
Page 175 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/01/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842516
Page 176 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Oct/01/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/1/2020
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 [BP3D95]
5.bSample ID [BPLL95]
5.cSample ID [BPLL96]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842517
Page 177 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Nov/19/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/19/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C1
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842518
Page 178 of 734
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 2 - Unscheduled
Visit on Nov/19/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/19/2020
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 [BPLL9S]
5.bSample ID [BPLL9T]
5.cSample ID [BP3DC2]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842519
Page 179 of 734
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/11/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/11/2020
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842520
Page 180 of 734
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/11/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Unplanned Assessments
1.Assessments Not Applicable Comments
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842521
Page 181 of 734
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/11/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842522
Page 182 of 734
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Dec/22/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842523
Page 183 of 734
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
:Mar/1/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: LOST TO FOLLOW-UP
4.Specify Status: [unable to contact 3 phone calls and cert. letter sent on 08FEB2021]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842524
Page 184 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842525
Page 185 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842526
Page 186 of 734
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  1+right distal cervical lymph
node enlarged Nov/8/2020 UN
K:UNK YES  Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842527
Page 187 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[1+right distal cervical lymph node enlarged]
4.Start Date Time: Nov/8/2020 UNK:UNK
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:
[Viral Syndrome]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842528
Page 188 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842529
Page 189 of 734
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842530
Page 190 of 734
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842531
Page 191 of 734
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842532
Page 192 of 734
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842533
Page 193 of 734
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842534
Page 194 of 734
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842535
Page 195 of 734
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842536
Page 196 of 734
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842537
Page 197 of 734
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842538
Page 198 of 734
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842539
Page 199 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842540
Page 200 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842541
Page 201 of 734
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842542
Page 202 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842543
Page 203 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842544
Page 204 of 734
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842545
Page 205 of 734
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842546
Page 206 of 734
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842547
Page 207 of 734
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842548
Page 208 of 734
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842549
Page 209 of 734
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842550
Page 210 of 734
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842551
Page 211 of 734
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842552
Page 212 of 734
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842553
Page 213 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Mar/1/2021
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842554
Page 214 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842555
Page 215 of 734
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Darrell
Herrington Approved Mar-02-2021 14:07:08 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DarrellHerrington, 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.
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842556
Page 216 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-11-2020 12:59:58 (UTC-06:00) Central
Time (US & Canada)covid test has not been completed to site
knowledge.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842557
Page 217 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Sep-11-2020 12:59:58 (UTC-06:00) Central
Time (US & Canada)covid test has not been completed to site
knowledge.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842558
Page 218 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Sep-11-2020 12:59:58 (UTC-06:00) Central
Time (US & Canada)covid test has not been completed to site
knowledge.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842559
Page 219 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Sep-11-2020 12:59:58 (UTC-06:00) Central
Time (US & Canada)covid test has not been completed to site
knowledge.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842560
Page 220 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Sep-11-2020 12:59:58 (UTC-06:00) Central
Time (US & Canada)covid test has not been completed to site
knowledge.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842561
Page 221 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Sep-11-2020 12:59:58 (UTC-06:00) Central
Time (US & Canada)covid test has not been completed to site
knowledge.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842562
Page 222 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Sep-11-2020 12:59:58 (UTC-06:00) Central
Time (US & Canada)covid test has not been completed to site
knowledge.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842563
Page 223 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
7Sep-11-2020 12:59:58 (UTC-06:00) Central
Time (US & Canada)covid test has not been completed to site
knowledge.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842564
Page 224 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
8Sep-11-2020 12:59:58 (UTC-06:00) Central
Time (US & Canada)covid test has not been completed to site
knowledge.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842565
Page 225 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
9Sep-11-2020 12:59:58 (UTC-06:00) Central
Time (US & Canada)covid test has not been completed to site
knowledge.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842566
Page 226 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: HEALTH CARE UTILIZATION - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-11-2020 13:08:29 (UTC-06:00) Central
Time (US & Canada)subject is non responsive to attempted calls. To
sites knowledge subject has not sought out
medical attention
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842567
Page 227 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-15-2020 14:33:10 (UTC-06:00) Central
Time (US & Canada)per ECRF guidelines, significant renal, hepatic
or neurological dysfunction as part of their
potential COVID-19 illness therefore this
section is not applicable
FormSep-15-2020 14:28:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842568
Page 228 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Sep-15-2020 14:28:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842569
Page 229 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Sep-15-2020 14:28:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842570
Page 230 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Sep-15-2020 14:28:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842571
Page 231 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/11/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Sep-15-2020 14:28:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842572
Page 232 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: DATE OF VISIT - ILLNESS ONSET - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-12-2020 11:08:48 (UTC-06:00) Central
Time (US & Canada)not applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842573
Page 233 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: DATE OF VISIT - ILLNESS ONSET - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-09-2020 16:49:09 (UTC-06:00) Central
Time (US & Canada)unable to remove date. Date entered in error
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842574
Page 234 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormMar-01-2021 16:29:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormFeb-26-2021 17:45:05 (UTC-06:00) Central
Time (US & Canada)not applicable
FormNov-02-2020 15:07:06 (UTC-06:00) Central
Time (US & Canada)not applicable visit is erroneous
FormOct-08-2020 16:29:44 (UTC-06:00) Central
Time (US & Canada)not applicable. data entry was done on wrong
subject.
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842575
Page 235 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Mar-01-2021 16:29:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1Feb-22-2021 12:41:58 (UTC-06:00) Central
Time (US & Canada)
1Nov-02-2020 16:01:04 (UTC-06:00) Central
Time (US & Canada)not applicable visit is erroneous
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842576
Page 236 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Mar-01-2021 16:29:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
2Feb-22-2021 12:42:26 (UTC-06:00) Central
Time (US & Canada)
2Nov-02-2020 16:01:34 (UTC-06:00) Central
Time (US & Canada)not applicable visit is erroneous
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842577
Page 237 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Mar-01-2021 16:29:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
3Feb-22-2021 12:50:31 (UTC-06:00) Central
Time (US & Canada)
3Nov-02-2020 16:01:56 (UTC-06:00) Central
Time (US & Canada)not applicable visit is erroneous
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842578
Page 238 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4.aMar-01-2021 16:29:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.aFeb-22-2021 12:56:51 (UTC-06:00) Central
Time (US & Canada)
4.aNov-02-2020 16:13:56 (UTC-06:00) Central
Time (US & Canada)not applicable visit is erroneous
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842579
Page 239 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4.bMar-01-2021 16:29:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.bFeb-22-2021 12:56:31 (UTC-06:00) Central
Time (US & Canada)
4.bNov-02-2020 16:15:25 (UTC-06:00) Central
Time (US & Canada)not applicable visit is erroneous
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842580
Page 240 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4.cMar-01-2021 16:29:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.cFeb-22-2021 12:55:34 (UTC-06:00) Central
Time (US & Canada)
4.cNov-02-2020 16:26:02 (UTC-06:00) Central
Time (US & Canada)not applicable visit is erroneous
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842581
Page 241 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4.dMar-01-2021 16:29:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.dFeb-22-2021 12:55:00 (UTC-06:00) Central
Time (US & Canada)
4.dNov-02-2020 16:26:40 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842582
Page 242 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4.eMar-01-2021 16:29:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.eFeb-22-2021 12:54:25 (UTC-06:00) Central
Time (US & Canada)
4.eNov-02-2020 16:26:55 (UTC-06:00) Central
Time (US & Canada)not applicable visit is erroneous
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842583
Page 243 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4 fMar-01-2021 16:29:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4 fFeb-22-2021 12:54:03 (UTC-06:00) Central
Time (US & Canada)
4 fNov-02-2020 16:27:14 (UTC-06:00) Central
Time (US & Canada)not applicable visit is erroneous
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842584
Page 244 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4.gMar-01-2021 16:29:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.gFeb-22-2021 12:52:58 (UTC-06:00) Central
Time (US & Canada)
4.gNov-02-2020 16:27:26 (UTC-06:00) Central
Time (US & Canada)not applicable visit is erroneous
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842585
Page 245 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4 hMar-01-2021 16:29:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4 hFeb-22-2021 12:52:36 (UTC-06:00) Central
Time (US & Canada)
4 hNov-02-2020 16:27:37 (UTC-06:00) Central
Time (US & Canada)not applicable visit is erroneous
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842586
Page 246 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4.iMar-01-2021 16:29:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
4.iFeb-22-2021 12:51:52 (UTC-06:00) Central
Time (US & Canada)
4.iNov-02-2020 16:14:56 (UTC-06:00) Central
Time (US & Canada)not applicable visit is erroneous
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842587
Page 247 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Oct/02/2020Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormNov-03-2020 12:36:43 (UTC-06:00) Central
Time (US & Canada)not applicable. data entry was completed on
wrong subject.
Not Applicable
FormOct-08-2020 16:30:25 (UTC-06:00) Central
Time (US & Canada)not applicable. data entry was done on wrong
subject.
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842588
Page 248 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1.aNov-03-2020 12:36:43 (UTC-06:00) Central
Time (US & Canada)not applicable. data entry was completed on
wrong subject.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842589
Page 249 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1.bNov-03-2020 12:36:43 (UTC-06:00) Central
Time (US & Canada)not applicable. data entry was completed on
wrong subject.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842590
Page 250 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1.cNov-03-2020 12:36:43 (UTC-06:00) Central
Time (US & Canada)not applicable. data entry was completed on
wrong subject.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842591
Page 251 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1.dNov-03-2020 12:36:43 (UTC-06:00) Central
Time (US & Canada)not applicable. data entry was completed on
wrong subject.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842592
Page 252 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1.eNov-03-2020 12:36:43 (UTC-06:00) Central
Time (US & Canada)not applicable. data entry was completed on
wrong subject.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842593
Page 253 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1 fNov-03-2020 12:36:43 (UTC-06:00) Central
Time (US & Canada)not applicable. data entry was completed on
wrong subject.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842594
Page 254 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Nov-03-2020 12:36:43 (UTC-06:00) Central
Time (US & Canada)not applicable. data entry was completed on
wrong subject.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842595
Page 255 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Nov-03-2020 12:36:43 (UTC-06:00) Central
Time (US & Canada)not applicable. data entry was completed on
wrong subject.
Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842596
Page 256 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-28-2020 12:02:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842597
Page 257 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-28-2020 12:02:36 (UTC-06:00) Central
Time (US & Canada)Not Done
1Oct-28-2020 12:00:13 (UTC-06:00) Central
Time (US & Canada)no non study covid test has been completed
Not Done
1Oct-26-2020 16:07:47 (UTC-06:00) Central
Time (US & Canada)no non study covid test has been completed
1Oct-26-2020 16:07:16 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842598
Page 258 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Oct-28-2020 12:02:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842599
Page 259 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Oct-28-2020 12:02:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842600
Page 260 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Oct-28-2020 12:02:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842601
Page 261 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Oct-28-2020 12:02:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842602
Page 262 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Oct-28-2020 12:02:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842603
Page 263 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
7Oct-28-2020 12:02:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842604
Page 264 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
8Oct-28-2020 12:02:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842605
Page 265 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 - Unscheduled Visit
on Oct/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
9Oct-28-2020 12:02:36 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842606
Page 266 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormNov-13-2020 09:48:50 (UTC-06:00) Central
Time (US & Canada)waiting for self swab
Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842607
Page 267 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Nov-13-2020 09:48:50 (UTC-06:00) Central
Time (US & Canada)waiting for self swab
Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842608
Page 268 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Nov-13-2020 09:48:50 (UTC-06:00) Central
Time (US & Canada)waiting for self swab
Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842609
Page 269 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Nov-13-2020 09:48:50 (UTC-06:00) Central
Time (US & Canada)waiting for self swab
Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842610
Page 270 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Nov-13-2020 09:48:50 (UTC-06:00) Central
Time (US & Canada)waiting for self swab
Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842611
Page 271 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Nov-13-2020 09:48:50 (UTC-06:00) Central
Time (US & Canada)waiting for self swab
Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842612
Page 272 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Nov-13-2020 09:48:50 (UTC-06:00) Central
Time (US & Canada)waiting for self swab
Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842613
Page 273 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
7Nov-13-2020 09:48:50 (UTC-06:00) Central
Time (US & Canada)waiting for self swab
Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842614
Page 274 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
8Nov-13-2020 09:48:50 (UTC-06:00) Central
Time (US & Canada)waiting for self swab
Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842615
Page 275 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 4 - Unscheduled Visit
on Nov/10/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
9Nov-13-2020 09:48:50 (UTC-06:00) Central
Time (US & Canada)waiting for self swab
Not Done
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842616
Page 276 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: DATE OF VISIT - ILLNESS ONSET - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormNov-23-2020 14:29:08 (UTC-06:00) Central
Time (US & Canada)visit is erroneous. EDC is updated
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842617
Page 277 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 - Unscheduled Visit
on Nov/19/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormNov-24-2020 14:59:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842618
Page 278 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Nov-24-2020 14:59:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842619
Page 279 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Nov-24-2020 14:59:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842620
Page 280 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Nov-24-2020 14:59:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842621
Page 281 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4.aNov-24-2020 14:59:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842622
Page 282 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4.bNov-24-2020 14:59:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842623
Page 283 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4.cNov-24-2020 14:59:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d54\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842624
Page 284 of 734
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 5 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site 
…[truncated]