125742 S1 M5 CRF c4591001 1118 11181044

Document text

Page 1 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797419
Page 2 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/17/2020
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797420
Page 3 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11181044]
2.Birth Date: /1947
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:
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797421
Page 4 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/17/2020
2.Erroneous Visit
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797422
Page 5 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797423
Page 6 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797424
Page 7 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/1990
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERLIPIDEMIA]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BRONCHIAL ASTHMA]
Start Date: UNK/UNK/1990
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ENVIRONMENTAL ALLERGIES]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797425
Page 8 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CORONARY ARTERY DISEASE]
Start Date: UNK/UNK/2011
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOARTHRITIS BILATERAL KNEE, HIP]
Start Date: UNK/UNK/1990
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PSORIASIS]
Start Date: UNK/UNK/1957
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALLERGY TO IODINE]
Start Date: UNK/UNK/1976
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOARTHRITIS SPINE]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797426
Page 9 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Aug/17/2020
2.Weight: [91.3]
3.Unit: kg
4.Height: [160.0]
5.Unit: cm
6.Body Mass Index: [35.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.8]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797427
Page 10 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/17/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797428
Page 11 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/17/2020
2.Randomization Number: [230544]
3.Randomization Group: [ ]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797429
Page 12 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/17/2020
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 [BP50H8]
5.bSample ID [BP50H9]
5.cSample ID [BP50HB]
5.dSample ID [BPR7X0]
5.eSample ID [BPR7X1]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797430
Page 13 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/17/2020
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 [BP50VK]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797431
Page 14 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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/17/2020 14:15
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797432
Page 15 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797433
Page 16 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797434
Page 17 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797435
Page 18 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/8/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797436
Page 19 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/8/2020
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 [BP50YS]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797437
Page 20 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/8/2020 14:15
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797438
Page 21 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797439
Page 22 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
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 [BP511D]
5.bSample ID [BPR85K]
5.cSample ID [BPR859]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797440
Page 23 of 392
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797441
Page 24 of 392
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/13/2020
2.Date of First Symptom Started: Oct/10/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/3/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797442
Page 25 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Nasal discharge]
5.bSymptoms - Other Text: [headache]
5.cSymptoms - Other Text: [fatigue]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797443
Page 26 of 392
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date of Colle
ctionSpecimen T
ypeSpecimen Collection L
ocationAssay Code and Desc
riptionDevice Typ
eForm Instanc
e
 1.Not Applicabl
e Not Applica
ble Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797444
Page 27 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797445
Page 28 of 392
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[swab done at clinic]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797446
Page 29 of 392
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
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 [BP512L]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797447
Page 30 of 392
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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:[ ]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797448
Page 31 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797449
Page 32 of 392
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Treatment Iden
tifierCon Non-Drug Treatments Pr
e-specifiedTreatment Treatment Start DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797450
Page 33 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797451
Page 34 of 392
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797452
Page 35 of 392
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicabl
e Repeating
Pages
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797453
Page 36 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797454
Page 37 of 392
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category for
Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Appli
cable Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797455
Page 38 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797456
Page 39 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797457
Page 40 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797458
Page 41 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797459
Page 42 of 392
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Category fo
r Lab TestVendor Name
(DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Applica
ble Not Applicable
 Not Appl
icable Not App
licable Sponsor-Defi
ned IdentifierTest: Result:
Not Applicabl
e Hemoglobi
n_PX1 Not App
licable 
Not Applicabl
e Hematocrit
_PX2 Not App
licable 
Not Applicabl
e Erythrocyte
s_PX3 Not App
licable 
Not Applicabl
e Platelets_P
X5 Not App
licable 
Not Applicabl
e Leukocytes
_PX7 Not App
licable 
Not Applicabl
e Neutrophils
_PX608 Not App
licable 
Not Applicabl
e Eosinophils
_PX609 Not App
licable 
Not Applicabl
e Monocytes
_PX612 Not App
licable 
Not Applicabl
e Basophils_
PX610 Not App
licable 
Not Applicabl
e Lymphocyt
es_PX611 Not App
licable Repeating
Pages
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797460
Page 43 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797461
Page 44 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797462
Page 45 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797463
Page 46 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5 fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797464
Page 47 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797465
Page 48 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797466
Page 49 of 392
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Date: Vital Signs Details Form Instance
 1.Oct/13/2020 Record Identifier: Systolic: Diastolic:
1  126  78 Repeating Pages
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797467
Page 50 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/13/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [126]
Diastolic: [78]
Respiratory Rate in
respirations/minute:[14]
Heart Rate in beats/minute: [84]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797468
Page 51 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Date: Vital Signs Details Form Instance
 1.Oct/13/2020 Record Identifier: Oxygen Saturation
1  96.0 Repeating Pages
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797469
Page 52 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Oct/13/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [96.0]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797470
Page 53 of 392
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date Time of Assessme
ntArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxyge
n)Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797471
Page 54 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797472
Page 55 of 392
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationStart Dat
eForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicabl
e Not Appli
cable Repeating
Pages
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797473
Page 56 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where
generic name is unknown, enter
the full trade or proprietary
name. Include clarifying
information in the Medication
text (e.g., Ingredient(s), route,
use, formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797474
Page 57 of 392
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797475
Page 58 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797476
Page 59 of 392
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/10/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/10/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797477
Page 60 of 392
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/10/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/10/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPR82L]
5.bSample ID [BPR87B]
5.cSample ID [BP5WT8]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797478
Page 61 of 392
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/01/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/1/2020
2.Erroneous Visit
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797479
Page 62 of 392
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/01/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797480
Page 63 of 392
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/01/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Dec/1/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [Subject was not experiencing any symptoms so a visit was not warranted.]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797481
Page 64 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/8/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797482
Page 65 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797483
Page 66 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797484
Page 67 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797485
Page 68 of 392
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  bilateral pulmonary
embolism Nov/11/2020 UN
K:UNK YES  Repeating
Pages
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797486
Page 69 of 392
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[bilateral pulmonary embolism]
4.Start Date Time: Nov/11/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797487
Page 70 of 392
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[pulmonary embolism]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020453551]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797488
Page 71 of 392
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797489
Page 72 of 392
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797490
Page 73 of 392
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart
DateForm Instanc
e
 1.          Repeating
Pages
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797491
Page 74 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: //
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797492
Page 75 of 392
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797493
Page 76 of 392
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where
generic name is unknown, enter
the full trade or proprietary
name. Include clarifying
information in the Medication
text (e.g., Ingredient(s), route,
use, formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797494
Page 77 of 392
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categor
yTreatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797495
Page 78 of 392
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797496
Page 79 of 392
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797497
Page 80 of 392
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797498
Page 81 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797499
Page 82 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797500
Page 83 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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:
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797501
Page 84 of 392
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797502
Page 85 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797503
Page 86 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797504
Page 87 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797505
Page 88 of 392
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797506
Page 89 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/13/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797507
Page 90 of 392
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797508
Page 91 of 392
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797509
Page 92 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797510
Page 93 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/26/2021
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797511
Page 94 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797512
Page 95 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/26/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797513
Page 96 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/26/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797514
Page 97 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRTCBG]
5.bSample ID [BRTCBX]
5.cSample ID [BPSS0S]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797515
Page 98 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRCJF8]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797516
Page 99 of 392
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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/26/2021 11:54
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797517
Page 100 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797518
Page 101 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/16/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797519
Page 102 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/16/2021
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 [BPSWPH]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797520
Page 103 of 392
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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/16/2021 13:58
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797521
Page 104 of 392
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797522
Page 105 of 392
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797523
Page 106 of 392
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797524
Page 107 of 392
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797525
Page 108 of 392
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797526
Page 109 of 392
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797527
Page 110 of 392
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797528
Page 111 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/8/2020
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797529
Page 112 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797530
Page 113 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Feb-17-2021 14:11:17 (UTC-05:00) Eastern
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.
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797531
Page 114 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormAug-17-2020 16:00:40 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797532
Page 115 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-15-2020 15:22:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797533
Page 116 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Oct-15-2020 15:22:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797534
Page 117 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Oct-15-2020 15:22:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797535
Page 118 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Oct-15-2020 15:22:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797536
Page 119 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Oct-15-2020 15:22:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797537
Page 120 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5Oct-15-2020 15:22:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
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Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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ItemDate User Comment
6Oct-15-2020 15:22:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
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FDA-CBER-2021-5683-0797539
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Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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ItemDate User Comment
7Oct-15-2020 15:22:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797540
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Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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ItemDate User Comment
8Oct-15-2020 15:22:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797541
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Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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ItemDate User Comment
9Oct-15-2020 15:22:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797542
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Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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ItemDate User Comment
FormOct-15-2020 15:22:58 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797543
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Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Oct-15-2020 15:22:58 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797544
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Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Oct-15-2020 15:22:58 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797545
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Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Oct-15-2020 15:22:58 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797546
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Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Oct-15-2020 15:22:58 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797547
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
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Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5Oct-15-2020 15:22:58 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797548
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Visit: POT_COVID_ILL 1 - Unscheduled
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Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6Oct-15-2020 15:22:58 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797549
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
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Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-13-2020 14:30:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797550
Page 133 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Oct-13-2020 14:30:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797551
Page 134 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Oct-13-2020 14:30:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797552
Page 135 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Oct-13-2020 14:30:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797553
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Oct-13-2020 14:30:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797554
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797555
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Oct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797556
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Oct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797557
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Oct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797558
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Oct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797559
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0797560
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0797561
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0797562
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0797563
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0797564
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0797565
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797566
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0797567
Page 150 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797568
Page 151 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797569
Page 152 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797570
Page 153 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
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Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled
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CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.dOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797575
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797576
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797577
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797578
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797579
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797580
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797581
Page 164 of 392
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797582
Page 165 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797583
Page 166 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797584
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797585
Page 168 of 392
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797586
Page 169 of 392
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gOct-13-2020 14:30:25 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797587
Page 170 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797588
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Oct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797589
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Oct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
2Oct-13-2020 14:34:09 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797590
Page 173 of 392
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Oct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
3Oct-15-2020 14:06:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797591
Page 174 of 392
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Oct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0797592
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797593
Page 176 of 392
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
- Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797594
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
- Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797595
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
- Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.aOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797596
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797597
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
- Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797598
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
- Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797599
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
- Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.bOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797600
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
- Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797601
Page 184 of 392
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
- Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.cOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797602
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***Confidential***
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Subject No: 11181044 Subject Initials: ---
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ItemDate User Comment
5.cOct-16-2020 07:27:51 (UTC-05:00) Eastern
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090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
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ItemDate User Comment
5.cOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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ItemDate User Comment
5.dOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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ItemDate User Comment
5.dOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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ItemDate User Comment
5.dOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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ItemDate User Comment
5.dOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0797608
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0797609
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0797610
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797611
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.eOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797612
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797613
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797614
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797615
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.fOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797616
Page 199 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
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(b) (4)
FDA-CBER-2021-5683-0797617
Page 200 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
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(b) (4)
FDA-CBER-2021-5683-0797618
Page 201 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
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(b) (4)
FDA-CBER-2021-5683-0797619
Page 202 of 392
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.gOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0797620
Page 203 of 392
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.hOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0797621
Page 204 of 392
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.hOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0797622
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.hOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0797623
Page 206 of 392
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.hOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0797624
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.iOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0797625
Page 208 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.iOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0797626
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.iOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0797627
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.iOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0797628
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.jOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
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FDA-CBER-2021-5683-0797629
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.jOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
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FDA-CBER-2021-5683-0797630
Page 213 of 392
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.jOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
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FDA-CBER-2021-5683-0797631
Page 214 of 392
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5.jOct-16-2020 07:27:51 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
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FDA-CBER-2021-5683-0797632
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Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-15-2020 14:07:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
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Page 216 of 392
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Visit: POT_COVID_ILL 1 - Unscheduled
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Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Oct-15-2020 14:07:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0797634
Page 217 of 392
***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Oct-15-2020 14:07:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797635
Page 218 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Oct-15-2020 14:07:31 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797636
Page 219 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-15-2020 14:07:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797637
Page 220 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Oct-15-2020 14:07:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797638
Page 221 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Oct-15-2020 14:07:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797639
Page 222 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Oct-15-2020 14:07:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797640
Page 223 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Oct-15-2020 14:07:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797641
Page 224 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
5Oct-15-2020 14:07:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797642
Page 225 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
6Oct-15-2020 14:07:48 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797643
Page 226 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-15-2020 14:08:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797644
Page 227 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
1Oct-15-2020 14:08:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797645
Page 228 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
2Oct-15-2020 14:08:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797646
Page 229 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
3Oct-15-2020 14:08:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797647
Page 230 of 392
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/13/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
4Oct-15-2020 14:08:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0797648
Page 231 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormJan-26-2021 13:12:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797649
Page 232 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Feb-17-2021 14:11:17 (UTC-05:00) Eastern
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 Feb-16-2021 14:45:19 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-09-2021 08:39:55 (UTC-05:00) Eastern
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 Jan-26-2021 13:11:36 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797650
Page 233 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Affidavit:
N/A
 Approved Jan-21-2021 17:01:29 (UTC-05:00) Eastern
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 Jan-14-2021 16:43:08 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Dec-02-2020 12:03:05 (UTC-05:00) Eastern
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 Dec-01-2020 16:48:33 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797651
Page 234 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
 Approved Nov-17-2020 13:35:18 (UTC-05:00)
Eastern 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-16-2020 18:08:05 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-11-2020 14:51:11 (UTC-05:00) Eastern
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-10-2020 11:49:48 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-16-2020 12:20:36 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797652
Page 235 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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-13-2020 14:21:45 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-12-2020 12:33:50 (UTC-05:00) Eastern
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 Oct-08-2020 16:47:15 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Sep-14-2020 14:41:08 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797653
Page 236 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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.
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797654
Page 237 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-17-2020 15:59:59
(UTC-05:00) Eastern
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-17-2020 15:59:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797655
Page 238 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-17-2020 16:00:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/17/2020Initial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797656
Page 239 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-17-2020 15:59:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11181044Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-17-2020 15:59:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1947Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-17-2020 16:00:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-17-2020 16:00:22
(UTC-05:00) Eastern
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-17-2020 16:00:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797657
Page 240 of 392
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-17-2020 16:00:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797658
Page 241 of 392
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-17-2020 16:00:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-17-2020 16:00:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-17-2020 16:00:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797659
Page 242 of 392
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Aug-17-2020 16:01:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:HYPERTEN
SION
Start Date: UNK/UNK/
1990
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-17-2020 16:01:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 16:01:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERTENSIONInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-17-2020 16:01:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797660
Page 243 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-17-2020 16:01:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-17-2020 16:02:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:HYPERLIPI
DEMIA
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797661
Page 244 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Line/MH Number:
Date Location User Value Reason
Aug-17-2020 16:02:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 16:02:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERLIPIDEMIAInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-17-2020 16:02:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-17-2020 16:02:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-17-2020 16:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:BRONCHIAL
ASTHMA
Start Date: UNK/UNK/19
90Initial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797662
Page 245 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Ongoing: YES
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797663
Page 246 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.c Line/MH Number:
Date Location User Value Reason
Aug-17-2020 16:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 14:39:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-19-2020 08:38:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Aug-18-2020 14:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened GPDCLIN - Please
confirm
BRONCHIAL
ASTHMA was
stable prior to
enrollment and
subject was not
receiving systemic
steroids for this
condition 28 Days
prior to study with
the exception of
Inhaled Steroids.
Aug-17-2020 16:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRONCHIAL ASTHMAInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-17-2020 16:02:24
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797664
Page 247 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
1.c Ongoing:
Date Location User Value Reason
Aug-17-2020 16:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-17-2020 16:02:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical Hi
story Term:ENVIRONMEN
TAL ALLERGIE
S
Start Date: UNK/UNK/1990
Ongoing: YESInitial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0797665
Page 248 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.d Line/MH Number:
Date Location User Value Reason
Aug-17-2020 16:02:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 16:02:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ENVIRONMENTAL ALLERG
IESInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-17-2020 16:02:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-17-2020 16:02:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-17-2020 16:03:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:CORONARY A
RTERY DISEAS
E
Start Date: UNK/UNK/2011Initial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797666
Page 249 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Aug-17-2020 16:03:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 16:03:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CORONARY ARTERY DISE
ASEInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-17-2020 16:03:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2011Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-17-2020 16:03:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-19-2020 08:38:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:6Changed
Information
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797667
Page 250 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Medical
History T
erm:OSTEOARTHRIT
IS BILATERAL K
NEE, HIP
Start Dat
e:UNK/UNK/1990
Ongoing: YES
Aug-17-2020 16:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical
History
Term:OSTEOARTHRITI
S BILATERAL KN
EE, HIP, SPINE
Start Da
te:UNK/UNK/1990
Ongoing
:YESInitial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797668
Page 251 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.f Line/MH Number:
Date Location User Value Reason
Aug-17-2020 16:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Aug-19-2020
13:59:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Clo
sedDiscrepancy has
been closed.
Aug-19-2020
08:38:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dChanged
Information
Aug-19-2020
08:38:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
OSTE
OAR
THRI
TIS B
ILAT
ERA
L KN
EE, H
IPChanged
Information
Aug-17-2020
22:22:52
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Op
enedMultiple concepts in
the term
OSTEOARTHRITIS
BILATERAL
KNEE, HIP, SPINE.
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0797669
Page 252 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Canada) Split the term into
OSTEOARTHRITIS
BILATERAL
KNEE, HIP and
OSTEOARTHRITIS
SPINE and report as
separate entries.
Thank you.
Aug-17-2020
16:03:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
OSTE
OAR
THRI
TIS B
ILAT
ERA
L KN
EE, H
IP, SP
INEInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-17-2020 16:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-17-2020 16:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797670
Page 253 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-17-2020 16:04:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:7
Medical History
Term:PSORIASIS
Start Date: UNK/UNK/
1957
Ongoing: YESInitial Entry
1.g Line/MH Number:
Date Location User Value Reason
Aug-17-2020 16:04:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 16:04:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PSORIASISInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-17-2020 16:04:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1957Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-17-2020 16:04:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797671
Page 254 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Aug-17-2020 16:04:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Histo
ry Term:ALLERGY T
O IODINE
Start Date: UNK/UNK/19
76
Ongoing: YESInitial Entry
1.h Line/MH Number:
Date Location User Value Reason
Aug-17-2020 16:04:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 16:04:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ALLERGY TO IODINEInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-17-2020 16:04:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1976Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-17-2020 16:04:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797672
Page 255 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.i
Date Location User Value Reason
Aug-19-2020 08:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:9
Medical Hist
ory Term:OSTEOARTH
RITIS SPINE
Start Date: UNK/UNK/199
0
Ongoing: YESInitial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0797673
Page 256 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.i Line/MH Number:
Date Location User Value Reason
Aug-19-2020 08:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-19-2020 08:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OSTEOARTHRITIS SPINEInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-19-2020 08:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-19-2020 08:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797674
Page 257 of 392
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Aug-17-2020 16:06:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-17-2020 16:06:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
91.3Initial Entry
3. Unit:
Date Location User Value Reason
Aug-17-2020 16:06:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-17-2020 16:06:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
160.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-17-2020 16:06:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797675
Page 258 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Aug-17-2020 16:06:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
35.7Initial Entry
7.a
Date Location User Value Reason
Aug-17-2020 16:06:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 36.8
Temperature Uni
t:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-17-2020 16:06:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-17-2020 16:06:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
36.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-17-2020 16:06:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797676
Page 259 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
7.a Temperature Location:
Date Location User Value Reason
Aug-17-2020 16:06:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797677
Page 260 of 392
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-17-2020 16:06:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-17-2020 16:06:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-17-2020 16:06:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-17-2020 16:06:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-17-2020 16:06:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797678
Page 261 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Aug-17-2020 16:06:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifie
r:113
Test:: Choriogonadotr
opin Beta_PX1
13
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-17-2020 16:06:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-17-2020 16:06:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-17-2020 16:06:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797679
Page 262 of 392
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-17-2020 16:06:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-17-2020 16:06:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
230544Initial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797680
Page 263 of 392
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-17-2020 16:07:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020 16:07:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020 16:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-17-2020 16:07:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-17-2020 16:07:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797681
Page 264 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-17-2020 16:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP50H8Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-17-2020 16:07:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP50H8Initial Entry
5.b
Date Location User Value Reason
Aug-17-2020 16:07:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP50H9Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-17-2020 16:07:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP50H9Initial Entry
5.c
Date Location User Value Reason
Aug-17-2020 16:08:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP50HBInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-17-2020 16:08:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP50HBInitial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797682
Page 265 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.d
Date Location User Value Reason
Aug-17-2020 16:08:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPR7X0Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-17-2020 16:08:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPR7X0Initial Entry
5.e
Date Location User Value Reason
Aug-17-2020 16:08:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPR7X1Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-17-2020 16:08:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPR7X1Initial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797683
Page 266 of 392
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-17-2020 16:09:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-17-2020 16:09:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020 16:10:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-17-2020 16:09:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-17-2020 16:09:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0797684
Page 267 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Aug-17-2020 16:10:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP50VKInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-17-2020 16:10:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP50VKInitial Entry
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797685
Page 268 of 392
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-17-2020 16:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-17-2020 16:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-17-2020 16:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-17-2020 16:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020 14:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-17-2020 16:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae40c8\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0797686
Page 269 of 392
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181044 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Aug-17-2020 16:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-17-2020 16:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSC
…[truncated]