Document text
Page 1 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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 version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843675
Page 2 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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/7/2020
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843676
Page 3 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11631059]
2.Birth Date: /1989
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843677
Page 4 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/7/2020
2.Erroneous Visit
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843678
Page 5 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843679
Page 6 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/7/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843680
Page 7 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843681
Page 8 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Aug/7/2020
2.Weight: [153.0]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [26.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843682
Page 9 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/7/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843683
Page 10 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/7/2020
2.Randomization Number: [44137]
3.Randomization Group: [ ]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843684
Page 11 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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/7/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP4397]
5.bSample ID [BP439P]
5.cSample ID [BP439R]
5.dSample ID [BP439S]
5.eSample ID [BPL17Z]
5.fSample ID [BPL180]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843685
Page 12 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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/7/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP437W]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843686
Page 13 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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/7/2020 12:19
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
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843687
Page 14 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843688
Page 15 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843689
Page 16 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843690
Page 17 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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?NO
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
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843691
Page 18 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843692
Page 19 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/27/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843693
Page 20 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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/27/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYYT0]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843694
Page 21 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?Not Done Comments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843695
Page 22 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843696
Page 23 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?Not Done Comments
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?Not Done Comments
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?Not Done Comments
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?Not Done Comments
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?Not Done Comments
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?Not Done Comments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843697
Page 24 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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?Not Done Comments
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?Not Done Comments
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?Not Done Comments
3.Injection Site Location: Not Done Comments
4.Injection Site Body Side: Not Done Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?Not Done Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?Not Done Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?Not Done Comments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843698
Page 25 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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:
Sep/24/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYYRP]
5.bSample ID [BPL0VJ]
5.cSample ID [BPL0VK]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843699
Page 26 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/21/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843700
Page 27 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/21/2020
2.Date of First Symptom Started: Dec/16/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/20/2020
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? YES
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843701
Page 28 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [HEADACHE]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843702
Page 29 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843703
Page 30 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843704
Page 31 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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:
Dec/21/2020
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 [RW86434]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843705
Page 32 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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:[SELF SWAB COLLECTED]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843706
Page 33 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843707
Page 34 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tTreatmen
tStart Dat
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done
Repeating Pages
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843708
Page 35 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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 Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843709
Page 36 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843710
Page 37 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
1.Not Done Not Done Not Done Not Done Repeating Pages
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843711
Page 38 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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 Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843712
Page 39 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined I
dentifierTest:Result:
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne
Not Done Not Do
ne Not Do
ne Repeating
Pages
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843713
Page 40 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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 Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843714
Page 41 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843715
Page 42 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843716
Page 43 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843717
Page 44 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Done Not Done Not Done Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one
Not Done Not D
one Not D
one Repeating
Pages
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843718
Page 45 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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 Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843719
Page 46 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843720
Page 47 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843721
Page 48 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843722
Page 49 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5 hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843723
Page 50 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843724
Page 51 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Systolic: Diastolic:
Not Done Not Done Not Done Repeating Pages
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843725
Page 52 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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 Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843726
Page 53 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Date: Vital Signs Details Form Instance
1.Not Done Record Identifier: Oxygen Saturation
Not Done Not Done Repeating Pages
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843727
Page 54 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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 Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843728
Page 55 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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 Done Not Done Not Done Repeating Pages
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843729
Page 56 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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 Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Done
[ ]Comments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843730
Page 57 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1.Not Done Not Done Not Done Not Done Not Do
ne Repeating
Pages
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843731
Page 58 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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 Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done 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 Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843732
Page 59 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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 Done Not Done Not Done Not Done Repeating Pages
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843733
Page 60 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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 Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843734
Page 61 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/18/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843735
Page 62 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/18/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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:
Jan/18/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1ZHP]
5.bSample ID [BNWS5N]
5.cSample ID [BNWS64]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843736
Page 63 of 463
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843737
Page 64 of 463
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843738
Page 65 of 463
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Aug/8/2020 Comments
2.Phase of Disposition: VACCINATION Comments
3.Status: ADVERSE EVENT Comments
4.Specify Status: [ ] Comments
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843739
Page 66 of 463
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843740
Page 67 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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:
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843741
Page 68 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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 [ ]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843742
Page 69 of 463
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Allergic Reaction to study inves
tigational product Aug/8/2020
08:00 NO
End Date Time:
Aug/25/2020 UNK:U
NK
Repeating
Pages
2.ADVERSE E
VENT 2 Allergic Reaction upper body ra
sh Aug/8/2020
08:00 NO
End Date Time:
Aug/25/2020 UNK:U
NK
Repeating
Pages
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843743
Page 70 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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)[Allergic Reaction to study investigational product]
4.Start Date Time: Aug/8/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/25/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843744
Page 71 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843745
Page 72 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Allergic Reaction upper body rash]
4.Start Date Time: Aug/8/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/25/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843746
Page 73 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843747
Page 74 of 463
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843748
Page 75 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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[ ]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843749
Page 76 of 463
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843750
Page 77 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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: //
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843751
Page 78 of 463
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
1. DELETED 1 CORTICOSTE
ROIDS NO PREDNISO
NE 20 Repeating
Pages
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843752
Page 79 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: CORTICOSTEROIDS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[PREDNISONE ]
5.Dose: [20]
6.Dose Unit: mg
7.Dose Frequency: BID
8.Route: ORAL
9.Start Date: Aug/22/2020
10.Ongoing? NO
End Date:
Aug/25/2020
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843753
Page 80 of 463
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843754
Page 81 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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?
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843755
Page 82 of 463
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843756
Page 83 of 463
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843757
Page 84 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843758
Page 85 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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:
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843759
Page 86 of 463
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843760
Page 87 of 463
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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?
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843761
Page 88 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843762
Page 89 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843763
Page 90 of 463
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843764
Page 91 of 463
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843765
Page 92 of 463
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843766
Page 93 of 463
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843767
Page 94 of 463
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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: [ ]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843768
Page 95 of 463
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843769
Page 96 of 463
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/19/2021
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843770
Page 97 of 463
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843771
Page 98 of 463
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/19/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843772
Page 99 of 463
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/19/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843773
Page 100 of 463
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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:
Jan/19/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1ZHS]
5.bSample ID [BNWS67]
5.cSample ID [BNWS68]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843774
Page 101 of 463
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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:
Jan/19/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1ZH5]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843775
Page 102 of 463
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/19/2021 10:34
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843776
Page 103 of 463
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843777
Page 104 of 463
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/8/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843778
Page 105 of 463
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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:
Feb/8/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1ZJ1]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843779
Page 106 of 463
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/8/2021 10:08
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843780
Page 107 of 463
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843781
Page 108 of 463
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/8/2021
3.Comments: [ ]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843782
Page 109 of 463
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843783
Page 110 of 463
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843784
Page 111 of 463
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843785
Page 112 of 463
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843786
Page 113 of 463
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Mar/8/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843787
Page 114 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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 Aug/8/2020
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843788
Page 115 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843789
Page 116 of 463
***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: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 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
George Bauer Approved Mar-11-2021 09:50:51 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeBauer, 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.
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843790
Page 117 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormAug-13-2020 10:01:56 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843791
Page 118 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormAug-12-2020 18:54:55 (UTC-06:00) Central
Time (US & Canada)NO SIGNIFICANT MEDICAL HISTORY
REPORTED. CONSIDER ADDING A
"NONE" BOX TO THIS FORM.
Not Applicable
FormAug-11-2020 10:08:59 (UTC-06:00) Central
Time (US & Canada)NO SIGNIFICANT MEDICAL HISTORY
REPORTED. CONSIDER ADDING A
"NONE" BOX TO THIS FORM.
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843792
Page 119 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-10-2020 15:02:12 (UTC-06:00) Central
Time (US & Canada)SECOND VACCINATION NOT GIVEN DUE
TO ALLERGIC REACTION TO FIRST
VACCINATION. THEREFORE THE FORM
CANNOT BE COMPLETED.
Not Done
FormAug-28-2020 19:02:54 (UTC-06:00) Central
Time (US & Canada)SECOND VACCINATION NOT GIVEN DUE
TO ALLERGIC REACTION TO FIRST
VACCINATION. THEREFORE THE FORM
CANNOT BE COMPLETED.
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843793
Page 120 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Sep-10-2020 15:02:12 (UTC-06:00) Central
Time (US & Canada)SECOND VACCINATION NOT GIVEN DUE
TO ALLERGIC REACTION TO FIRST
VACCINATION. THEREFORE THE FORM
CANNOT BE COMPLETED.
Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843794
Page 121 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Sep-10-2020 15:02:12 (UTC-06:00) Central
Time (US & Canada)SECOND VACCINATION NOT GIVEN DUE
TO ALLERGIC REACTION TO FIRST
VACCINATION. THEREFORE THE FORM
CANNOT BE COMPLETED.
Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843795
Page 122 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Sep-10-2020 15:02:12 (UTC-06:00) Central
Time (US & Canada)SECOND VACCINATION NOT GIVEN DUE
TO ALLERGIC REACTION TO FIRST
VACCINATION. THEREFORE THE FORM
CANNOT BE COMPLETED.
Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843796
Page 123 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Sep-10-2020 15:02:12 (UTC-06:00) Central
Time (US & Canada)SECOND VACCINATION NOT GIVEN DUE
TO ALLERGIC REACTION TO FIRST
VACCINATION. THEREFORE THE FORM
CANNOT BE COMPLETED.
Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843797
Page 124 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Sep-10-2020 15:02:12 (UTC-06:00) Central
Time (US & Canada)SECOND VACCINATION NOT GIVEN DUE
TO ALLERGIC REACTION TO FIRST
VACCINATION. THEREFORE THE FORM
CANNOT BE COMPLETED.
Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843798
Page 125 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Sep-10-2020 15:02:12 (UTC-06:00) Central
Time (US & Canada)SECOND VACCINATION NOT GIVEN DUE
TO ALLERGIC REACTION TO FIRST
VACCINATION. THEREFORE THE FORM
CANNOT BE COMPLETED.
Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843799
Page 126 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
7Sep-10-2020 15:02:12 (UTC-06:00) Central
Time (US & Canada)SECOND VACCINATION NOT GIVEN DUE
TO ALLERGIC REACTION TO FIRST
VACCINATION. THEREFORE THE FORM
CANNOT BE COMPLETED.
Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843800
Page 127 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
8Sep-10-2020 15:02:12 (UTC-06:00) Central
Time (US & Canada)SECOND VACCINATION NOT GIVEN DUE
TO ALLERGIC REACTION TO FIRST
VACCINATION. THEREFORE THE FORM
CANNOT BE COMPLETED.
Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843801
Page 128 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
9Sep-10-2020 15:02:12 (UTC-06:00) Central
Time (US & Canada)SECOND VACCINATION NOT GIVEN DUE
TO ALLERGIC REACTION TO FIRST
VACCINATION. THEREFORE THE FORM
CANNOT BE COMPLETED.
Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843802
Page 129 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
10Sep-10-2020 15:02:12 (UTC-06:00) Central
Time (US & Canada)SECOND VACCINATION NOT GIVEN DUE
TO ALLERGIC REACTION TO FIRST
VACCINATION. THEREFORE THE FORM
CANNOT BE COMPLETED.
Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843803
Page 130 of 463
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
11Sep-10-2020 15:02:12 (UTC-06:00) Central
Time (US & Canada)SECOND VACCINATION NOT GIVEN DUE
TO ALLERGIC REACTION TO FIRST
VACCINATION. THEREFORE THE FORM
CANNOT BE COMPLETED.
Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843804
Page 131 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-30-2020 09:34:57 (UTC-06:00) Central
Time (US & Canada)Julia Henry subject did not complete vaccination diary
FormSep-24-2020 13:18:04 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843805
Page 132 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Sep-24-2020 13:18:04 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843806
Page 133 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aSep-24-2020 13:18:04 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843807
Page 134 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.bSep-24-2020 13:18:04 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843808
Page 135 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.cSep-24-2020 13:18:04 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843809
Page 136 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.dSep-24-2020 13:18:04 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843810
Page 137 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.eSep-24-2020 13:18:04 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843811
Page 138 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2 fSep-24-2020 13:18:04 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843812
Page 139 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.gSep-24-2020 13:18:04 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843813
Page 140 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2 hSep-24-2020 13:18:04 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843814
Page 141 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Sep-24-2020 13:18:04 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843815
Page 142 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Sep-24-2020 13:18:04 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843816
Page 143 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aSep-24-2020 13:18:04 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843817
Page 144 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bSep-24-2020 13:18:04 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843818
Page 145 of 463
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cSep-24-2020 13:18:04 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843819
Page 146 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-22-2020 07:25:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843820
Page 147 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Dec-22-2020 07:25:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843821
Page 148 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Dec-22-2020 07:25:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843822
Page 149 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Dec-22-2020 07:25:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843823
Page 150 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Dec-22-2020 07:25:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843824
Page 151 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Dec-22-2020 07:25:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843825
Page 152 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Dec-22-2020 07:25:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843826
Page 153 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
7Dec-22-2020 07:25:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843827
Page 154 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
8Dec-22-2020 07:25:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843828
Page 155 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
9Dec-22-2020 07:25:27 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843829
Page 156 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-22-2020 07:27:06 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843830
Page 157 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Dec-22-2020 07:27:06 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843831
Page 158 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Dec-22-2020 07:27:06 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843832
Page 159 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Dec-22-2020 07:27:06 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843833
Page 160 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Dec-22-2020 07:27:06 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843834
Page 161 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Dec-22-2020 07:27:06 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843835
Page 162 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Dec-22-2020 07:27:06 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843836
Page 163 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-22-2020 07:27:35 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843837
Page 164 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Dec-22-2020 07:27:35 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843838
Page 165 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Dec-22-2020 07:27:35 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843839
Page 166 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Dec-22-2020 07:27:35 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843840
Page 167 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Dec-22-2020 07:27:35 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843841
Page 168 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843842
Page 169 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Dec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843843
Page 170 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Dec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843844
Page 171 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Dec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843845
Page 172 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Dec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843846
Page 173 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843847
Page 174 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843848
Page 175 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843849
Page 176 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843850
Page 177 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843851
Page 178 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843852
Page 179 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843853
Page 180 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843854
Page 181 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843855
Page 182 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843856
Page 183 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843857
Page 184 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843858
Page 185 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843859
Page 186 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843860
Page 187 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843861
Page 188 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843862
Page 189 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843863
Page 190 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843864
Page 191 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843865
Page 192 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843866
Page 193 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 fDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843867
Page 194 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 fDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843868
Page 195 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 fDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843869
Page 196 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 fDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843870
Page 197 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843871
Page 198 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843872
Page 199 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843873
Page 200 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gDec-22-2020 07:27:53 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843874
Page 201 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843875
Page 202 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Dec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843876
Page 203 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Dec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843877
Page 204 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Dec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843878
Page 205 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Dec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843879
Page 206 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843880
Page 207 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843881
Page 208 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843882
Page 209 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843883
Page 210 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843884
Page 211 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843885
Page 212 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843886
Page 213 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843887
Page 214 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843888
Page 215 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843889
Page 216 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843890
Page 217 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843891
Page 218 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843892
Page 219 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843893
Page 220 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843894
Page 221 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843895
Page 222 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843896
Page 223 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843897
Page 224 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843898
Page 225 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843899
Page 226 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 fDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843900
Page 227 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 fDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843901
Page 228 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 fDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843902
Page 229 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 fDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843903
Page 230 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843904
Page 231 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843905
Page 232 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843906
Page 233 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843907
Page 234 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 hDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843908
Page 235 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 hDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843909
Page 236 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 hDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843910
Page 237 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 hDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843911
Page 238 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.iDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843912
Page 239 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.iDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843913
Page 240 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.iDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843914
Page 241 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.iDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843915
Page 242 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.jDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843916
Page 243 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.jDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843917
Page 244 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.jDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843918
Page 245 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.jDec-22-2020 07:28:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843919
Page 246 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-22-2020 07:28:37 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843920
Page 247 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Dec-22-2020 07:28:37 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843921
Page 248 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aDec-22-2020 07:28:37 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843922
Page 249 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aDec-22-2020 07:28:37 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843923
Page 250 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aDec-22-2020 07:28:37 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843924
Page 251 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aDec-22-2020 07:28:37 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843925
Page 252 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-22-2020 07:28:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843926
Page 253 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Dec-22-2020 07:28:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843927
Page 254 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aDec-22-2020 07:28:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843928
Page 255 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-22-2020 07:29:14 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843929
Page 256 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Dec-22-2020 07:29:14 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843930
Page 257 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Dec-22-2020 07:29:14 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843931
Page 258 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Dec-22-2020 07:29:14 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843932
Page 259 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-22-2020 07:29:31 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843933
Page 260 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Dec-22-2020 07:29:31 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843934
Page 261 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Dec-22-2020 07:29:31 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843935
Page 262 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Dec-22-2020 07:29:31 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843936
Page 263 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Dec-22-2020 07:29:31 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843937
Page 264 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Dec-22-2020 07:29:31 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843938
Page 265 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Dec-22-2020 07:29:31 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843939
Page 266 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-22-2020 07:29:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843940
Page 267 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Dec-22-2020 07:29:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843941
Page 268 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Dec-22-2020 07:29:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843942
Page 269 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Dec-22-2020 07:29:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843943
Page 270 of 463
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/21/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Dec-22-2020 07:29:48 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843944
Page 271 of 463
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-21-2020 16:41:45 (UTC-06:00) Central
Time (US & Canada)Julia Henry
FormSep-18-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843945
Page 272 of 463
***Confidential***
Header Text: c4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Sep-21-2020 16:41:45 (UTC-06:00) Central
Time (US & Canada)Julia Henry
1Sep-18-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843946
Page 273 of 463
***Confidential***
Header Text: c4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Sep-21-2020 16:41:45 (UTC-06:00) Central
Time (US & Canada)Julia Henry
2Sep-18-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843947
Page 274 of 463
***Confidential***
Header Text: c4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Sep-21-2020 16:41:45 (UTC-06:00) Central
Time (US & Canada)Julia Henry
3Sep-18-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843948
Page 275 of 463
***Confidential***
Header Text: c4591001
Visit: End of Treatment Form: DISPOSITION - TREATMENT - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Sep-21-2020 16:41:45 (UTC-06:00) Central
Time (US & Canada)Julia Henry
4Sep-18-2020 14:43:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0843949
Page 276 of 463
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-22-2021 17:38:16 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0843950
Page 277 of 463
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
George Bauer Approved Mar-11-2021 09:50:51 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeBauer, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-03-2021 00:35:56 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
George Bauer Approved Jan-25-2021 12:30:17 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeBauer, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-14-2020 16:16:42 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843951
Page 278 of 463
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Approved Nov-17-2020 15:35:01 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-17-2020 12:46:05 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-17-2020 09:57:58 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-12-2020 18:06:48 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-12-2020 11:09:58 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843952
Page 279 of 463
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-11-2020 13:56:12 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-09-2020 17:15:11 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-09-2020 12:15:29 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-23-2020 16:29:26 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843953
Page 280 of 463
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
By my dated signature below, I , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-22-2020 16:26:25 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
George Bauer Approved Oct-13-2020 15:19:46 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeBauer, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Sep-24-2020 13:17:04 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
George Bauer Approved Sep-21-2020 17:59:19 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843954
Page 281 of 463
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
By my dated signature below, I, GeorgeBauer, 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.
Julia Henry N/A Sep-21-2020 16:41:45 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
George Bauer Approved Sep-19-2020 19:35:04 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeBauer, 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.
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0843955
Page 282 of 463
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-07-2020 13:27:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-07-2020 13:27:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843956
Page 283 of 463
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-07-2020 13:27:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/7/2020Initial Entry
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843957
Page 284 of 463
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-07-2020 13:27:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11631059Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-12-2020 03:29:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-11-2020 18:32:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Aug-11-2020 18:32:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
/1989Transcription Error
Aug-11-2020 10:33:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened IVRS
Reconciliation :
Subject age
calculated '66'
based on DOB and
randomization date
observed outside
the acceptable age
group (18 to 55)
specified per
(Strata) IVRS.
Please check and
update data as
appropriate. Else,
clarify. Thank you.
Aug-07-2020 13:27:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc (autocalc) Data Entry:
Aug/1/1954Enrollment Entry
3. Sex:
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843958
Page 285 of 463
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-07-2020 13:28:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-07-2020 13:28:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-07-2020 13:28:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0843959
Page 286 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-14-2020 00:47:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Aug-13-2020 10:02:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered FORM LEVEL
COMMENT
MADE.
Aug-13-2020 08:42:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened DM Query: As per
Protocol
Amendment 5
(24Jul2020). INC
EXC form is not
applicable. Please
add Form level
comment “Not
Applicable”.
Aug-13-2020 01:40:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Aug-12-2020 18:56:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered FORM LEVEL
COMMENT
ADDED
Aug-12-2020 04:36:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened DM Query: Thank
you or adding
comment on
‘GENERAL
MEDICAL
HISTORY’ form at
this visit. Please
consider to mark
this form as Not
applicable. Thank
you.
Aug-12-2020 03:30:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Form level
comment added to
MH page
090177e196ae2f94\Final\Final On: 01-Apr-2021 03:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0843960
Page 287 of 463
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1163 Site Name: (1163) Benchmark Urgent Family Care
Subject No: 11631059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-11-2020 10:09:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered NO SIGNIFICANT
MEDICAL
HISTORY
REPORTED.
CONSIDER
ADDING A
"NONE" B
…[truncated]