125742 S1 M5 CRF c4591001 1170 11701217

Document text

Page 1 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944072
Page 2 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/8/2020
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944073
Page 3 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11701217]
2.Birth Date: /1963
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944074
Page 4 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944075
Page 5 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944076
Page 6 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/8/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944077
Page 7 of 507
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/1998
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Deep Vein Thrombosis (DVT)]
Start Date: UNK/UNK/1980
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type II Diabetes]
Start Date: UNK/UNK/1998
Ongoing: YES
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944078
Page 8 of 507
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/1963
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tobacco Use]
Start Date: UNK/UNK/1995
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Alcoholism]
Start Date: UNK/UNK/2010
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Idiopathic Thrombocytopenic Purpura]
Start Date: UNK/UNK/2006
Ongoing: YES
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944079
Page 9 of 507
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obstructive Sleep Apnea]
Start Date: UNK/UNK/2010
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: UNK/UNK/2020
Ongoing: YES
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944080
Page 10 of 507
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
2.Weight: [164.2]
3.Unit: kg
4.Height: [182.88]
5.Unit: cm
6.Body Mass Index: [49.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.0]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944081
Page 11 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/8/2020
2.Randomization Number: [254081]
3.Randomization Group: [ ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944082
Page 12 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/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 [BP9BKV]
5.bSample ID [BNW6JG]
5.cSample ID [BNW6JZ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944083
Page 13 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
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 [BP9BK0]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944084
Page 14 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/8/2020 11:05
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
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944085
Page 15 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944086
Page 16 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/29/2020
2.Erroneous Visit
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944087
Page 17 of 507
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944088
Page 18 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
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 [BGJKTY]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944089
Page 19 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/29/2020 10:06
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
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944090
Page 20 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944091
Page 21 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS51ZV]
5.bSample ID [BS51ZW]
5.cSample ID [BR7RWJ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944092
Page 22 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/18/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944093
Page 23 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/18/2020
2.Date of First Symptom
Started:Oct/17/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/21/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944094
Page 24 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Fatigue]
5.bSymptoms - Other Text: [Malaise]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944095
Page 25 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of
Collecti
onSpecimen
TypeSpecimen Co
llection Loca
tionAssay Code and Descrip
tionDevice TypeForm Insta
nce
 1.Oct/19/2
020 SWABBE
D MATERI
AL NASOPHAR
YNX SEVERE ACUTE RESP
SYNDROME CORONA
VIRUS 2 SARS-COV-2
DIAGNOSTIC
TEST Repeating
Pages
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944096
Page 26 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/19/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection
Location:NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944097
Page 27 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/18/2020
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 [CV20549]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944098
Page 28 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[subject instructed to self swab.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944099
Page 29 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944100
Page 30 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944101
Page 31 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment Id
entifierCon Non-Drug Treatment
s Pre-specifiedTreatmen
tTreatmen
tStart Dat
eForm Instanc
e
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944102
Page 32 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment
Identifier?Not Applicable
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944103
Page 33 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944104
Page 34 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinical
Event:Subcategory of Clinica
l EventDiagnosis Obta
inedToxicity Gr
adeForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944105
Page 35 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical
Event:Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944106
Page 36 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category f
or Lab TestVendor
NameCollecti
on Date:Specim
en TypeLab ResultForm Instan
ce
 1.Not Applica
ble Not App
licable Not App
licable Not App
licable Sponsor-Defi
ned Identifie
rTest:Result:
Not Applicabl
e Not Ap
plicable
 Not Ap
plicable
 
Not Applicabl
e Not Ap
plicable
 Not Ap
plicable
 
Not Applicabl
e Not Ap
plicable
 Not Ap
plicable
 
Not Applicabl
e Not Ap
plicable
 Not Ap
plicable
 
Not Applicabl
e Not Ap
plicable
 Not Ap
plicable
 
Not Applicabl
e Not Ap
plicable
 Not Ap
plicable
 
Not Applicabl
e Not Ap
plicable
 Not Ap
plicable
 Repeating
Pages
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944107
Page 37 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and
AddressNot 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
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944108
Page 38 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
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
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944109
Page 39 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944110
Page 40 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944111
Page 41 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944112
Page 42 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944113
Page 43 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944114
Page 44 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category f
or Lab Te
stVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 1.Not Applic
able Not Applicab
le Not Ap
plicable Not Ap
plicable
 Sponsor-Def
ined Identifi
erTest:Result:
Not Applica
ble Not Ap
plicable
 Not Ap
plicable
 
Not Applica
ble Not Ap
plicable
 Not Ap
plicable
 
Not Applica
ble Not Ap
plicable
 Not Ap
plicable
 
Not Applica
ble Not Ap
plicable
 Not Ap
plicable
 
Not Applica
ble Not Ap
plicable
 Not Ap
plicable
 
Not Applica
ble Not Ap
plicable
 Not Ap
plicable
 
Not Applica
ble Not Ap
plicable
 Not Ap
plicable
 
Not Applica
ble Not Ap
plicableNot Ap
plicableRepeating
Pages
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944115
Page 45 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category f
or Lab Te
stVendor Nam
e (DERIVE
D)Collecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
Sponsor-Def
ined Identifi
erTest:Result:
   
Not Applica
ble Not Ap
plicable
 Not Ap
plicable
 
Not Applica
ble Not Ap
plicable
 Not Ap
plicable
 
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944116
Page 46 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and
AddressNot 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
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944117
Page 47 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944118
Page 48 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944119
Page 49 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944120
Page 50 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944121
Page 51 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944122
Page 52 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944123
Page 53 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944124
Page 54 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944125
Page 55 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944126
Page 56 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944127
Page 57 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944128
Page 58 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944129
Page 59 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944130
Page 60 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date Time of Assess
mentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled O
xygen)Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating
Pages
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944131
Page 61 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944132
Page 62 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medicat
ions Pre-specifiedName of M
edicationStart Da
teForm Instan
ce
 1.Not Applicable  Not Applicabl
e Not Applicable  Not Applica
ble Not App
licable Repeating
Pages
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944133
Page 63 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication
identifier?Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic
drug name (including salt
form, where applicable).
Where generic name is
unknown, enter the full trade
or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944134
Page 64 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Assessme
ntLocation of Assessm
entImaging Meth
odOverall Assessme
ntForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating
Pages
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944135
Page 65 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944136
Page 66 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/19/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/19/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944137
Page 67 of 507
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/19/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/19/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRTW81]
5.bSample ID [BRTW80]
5.cSample ID [BR7S80]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944138
Page 68 of 507
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944139
Page 69 of 507
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944140
Page 70 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/27/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944141
Page 71 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944142
Page 72 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944143
Page 73 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944144
Page 74 of 507
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Cellulitis of left
lower leg Oct/1/2020 U
NK:UNK NO
End Date Time:
Nov/1/2020 UNK:
UNK
 Repeating
Pages
 2.ADVERSE
EVENT 2  Neutropenia  Oct/1/2020 U
NK:UNK NO
End Date Time:
Nov/1/2020 UNK:
UNK
 Repeating
Pages
 3.ADVERSE
EVENT 3  Thrombocytope
nia Oct/1/2020 U
NK:UNK NO
End Date Time:
Nov/1/2020 UNK:
UNK
 Repeating
Pages
 4.ADVERSE
EVENT 4  Wound of left l
ower leg Sep/12/2020 U
NK:UNK NO
End Date Time:
Sep/30/2020 UNK:
UNK
 Repeating
Pages
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944145
Page 75 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Cellulitis of left lower leg]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/1/2020 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944146
Page 76 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[underline comorbidities pt with a hx of Type II Diabetes and
morbid obesity]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944147
Page 77 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[2020389615]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944148
Page 78 of 507
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Neutropenia]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/1/2020 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944149
Page 79 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[underline comorbidities pt with a hx of Type II Diabetes and
morbid obesity]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944150
Page 80 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[2020389615]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944151
Page 81 of 507
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Thrombocytopenia]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Nov/1/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944152
Page 82 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Cellulitis]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944153
Page 83 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[2020389615]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944154
Page 84 of 507
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Wound of left lower leg]
4.Start Date Time: Sep/12/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/30/2020 UNK:UNK
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).NO
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944155
Page 85 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[injury to leg.]
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?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944156
Page 86 of 507
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categ
oryMedication
ErrorStart
DateIs the medication error
Still OngoingStudy Medication Er
rors ActionForm Instanc
e
 1.         Repeating
Pages
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944157
Page 87 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944158
Page 88 of 507
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medicat
ions Pre-specifiedName of M
edicationStart Da
teForm Instan
ce
 1.1  VACCINATIO
NS NO  Pneumonia
Vaccine Sep/UN
K/2020 Repeating
Pages
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944159
Page 89 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic
drug name (including salt
form, where applicable).
Where generic name is
unknown, enter the full trade
or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Pneumonia Vaccine]
5.Date: Sep/UNK/2020
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944160
Page 90 of 507
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944161
Page 91 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt
form, where applicable).
Where generic name is
unknown, enter the full trade
or proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944162
Page 92 of 507
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryTreatment Iden
tifierCon Non-Drug Treatments Pr
e-specifiedTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944163
Page 93 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944164
Page 94 of 507
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944165
Page 95 of 507
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944166
Page 96 of 507
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944167
Page 97 of 507
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944168
Page 98 of 507
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vaccination
1.Was there a temporary delay
of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944169
Page 99 of 507
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944170
Page 100 of 507
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944171
Page 101 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944172
Page 102 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response -
Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944173
Page 103 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944174
Page 104 of 507
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944175
Page 105 of 507
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944176
Page 106 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944177
Page 107 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/20/2021
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944178
Page 108 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944179
Page 109 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/20/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944180
Page 110 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/20/2021
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 [BSGDBF]
5.bSample ID [BSGDBG]
5.cSample ID [BPSBXR]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944181
Page 111 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/20/2021
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 [BPSBXN]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944182
Page 112 of 507
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/20/2021 08:30
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
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944183
Page 113 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944184
Page 114 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/10/2021
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 [BPSBDJ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944185
Page 115 of 507
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/10/2021 08:30
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
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944186
Page 116 of 507
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944187
Page 117 of 507
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/10/2021
3.Comments: [ ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944188
Page 118 of 507
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944189
Page 119 of 507
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944190
Page 120 of 507
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944191
Page 121 of 507
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944192
Page 122 of 507
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/10/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944193
Page 123 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/27/2020
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944194
Page 124 of 507
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944195
Page 125 of 507
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Mezgebe
Berhe Approved Mar-12-2021 15:36:52 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MezgebeBerhe, 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.
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944196
Page 126 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-08-2020 11:56:43 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944197
Page 127 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-30-2020 10:47:11 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944198
Page 128 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-30-2020 10:47:11 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944199
Page 129 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Oct-30-2020 10:47:11 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944200
Page 130 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Oct-30-2020 10:47:11 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944201
Page 131 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Oct-30-2020 10:47:11 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944202
Page 132 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Oct-30-2020 10:47:11 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944203
Page 133 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Oct-30-2020 10:47:11 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944204
Page 134 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-30-2020 10:47:31 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944205
Page 135 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-30-2020 10:47:31 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944206
Page 136 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Oct-30-2020 10:47:31 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944207
Page 137 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Oct-30-2020 10:47:31 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944208
Page 138 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Oct-30-2020 10:47:31 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944209
Page 139 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944210
Page 140 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944211
Page 141 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Oct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944212
Page 142 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Oct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944213
Page 143 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Oct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944214
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Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
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Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944216
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944217
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944218
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944219
Page 149 of 507
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944220
Page 150 of 507
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944221
Page 151 of 507
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944222
Page 152 of 507
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944223
Page 153 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944224
Page 154 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944225
Page 155 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944226
Page 156 of 507
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944227
Page 157 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944228
Page 158 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944229
Page 159 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944230
Page 160 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944231
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944232
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944233
Page 163 of 507
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944234
Page 164 of 507
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.fOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944235
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.fOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944236
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.fOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944237
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.fOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944238
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944239
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944240
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944241
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gOct-30-2020 10:52:08 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944242
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944243
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944244
Page 174 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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ItemDate User Comment
2Oct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
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(b) (6)
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Oct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944246
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Oct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944247
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944248
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944249
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944250
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944251
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944252
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944253
Page 183 of 507
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944254
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944255
Page 185 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944256
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944257
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944258
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944259
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944260
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944261
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944262
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944263
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944264
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944265
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944266
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944267
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.fOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944268
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.fOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944269
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.fOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944270
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.fOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944271
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944272
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944273
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***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944274
Page 204 of 507
***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944275
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Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
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ItemDate User Comment
5.hOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
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(b) (6)
(b) (4)
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Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.hOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
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Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.hOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944278
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Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.hOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944279
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Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.iOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944280
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Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.iOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944281
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Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.iOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944282
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.iOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944283
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Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.jOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944284
Page 214 of 507
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.jOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944285
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.jOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944286
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.jOct-30-2020 10:52:23 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944287
Page 217 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-30-2020 10:52:38 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944288
Page 218 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-30-2020 10:52:38 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944289
Page 219 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aOct-30-2020 10:52:38 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944290
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aOct-30-2020 10:52:38 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944291
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Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aOct-30-2020 10:52:38 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944292
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aOct-30-2020 10:52:38 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0944293
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-30-2020 10:52:55 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
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(b) (6)
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FDA-CBER-2021-5683-0944294
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Unscheduled Visit on Oct/18/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-30-2020 10:52:55 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
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FDA-CBER-2021-5683-0944295
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: VITAL SIGNS - PULSE OX ROOM AIR -
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Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aOct-30-2020 10:52:55 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
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FDA-CBER-2021-5683-0944296
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***Confidential***
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Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-30-2020 10:54:13 (UTC-06:00)
Central Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0944297
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: OXYGENATION PARAMETERS - Comments
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Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-30-2020 10:54:13 (UTC-06:00)
Central Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0944298
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Unscheduled Visit on Oct/18/2020Form: OXYGENATION PARAMETERS - Comments
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Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Oct-30-2020 10:54:13 (UTC-06:00)
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Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Oct-30-2020 10:54:13 (UTC-06:00)
Central Time (US & Canada)Not Applicable
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Unscheduled Visit on Oct/18/2020Form: CONCOMITANT MEDICATIONS -
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Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-30-2020 10:54:24 (UTC-06:00)
Central Time (US & Canada)Not Applicable
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Unscheduled Visit on Oct/18/2020Form: CONCOMITANT MEDICATIONS -
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-30-2020 10:54:24 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
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Unscheduled Visit on Oct/18/2020Form: CONCOMITANT MEDICATIONS -
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Oct-30-2020 10:54:24 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
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FDA-CBER-2021-5683-0944303
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***Confidential***
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Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: CONCOMITANT MEDICATIONS -
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Oct-30-2020 10:54:24 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
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FDA-CBER-2021-5683-0944304
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Oct-30-2020 10:54:24 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
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FDA-CBER-2021-5683-0944305
Page 235 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: CONCOMITANT MEDICATIONS -
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Oct-30-2020 10:54:24 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944306
Page 236 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Oct-30-2020 10:54:24 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944307
Page 237 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormOct-30-2020 10:54:37 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944308
Page 238 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Oct-30-2020 10:54:37 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944309
Page 239 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Oct-30-2020 10:54:37 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944310
Page 240 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Oct-30-2020 10:54:37 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944311
Page 241 of 507
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/18/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Oct-30-2020 10:54:37 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944312
Page 242 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-20-2021 14:58:27 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944313
Page 243 of 507
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Mezgebe
Berhe Approved Mar-12-2021 15:36:52 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MezgebeBerhe, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
 N/A Feb-10-2021 11:02:03 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mezgebe
Berhe Approved Jan-21-2021 15:47:54 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944314
Page 244 of 507
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
By my dated signature below, I, MezgebeBerhe, 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-21-2020 10:01:22 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mezgebe
Berhe Approved Nov-25-2020 10:39:59 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MezgebeBerhe, 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-19-2020 09:58:12 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944315
Page 245 of 507
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
N/A
Mezgebe
Berhe Approved Nov-13-2020 19:13:37 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MezgebeBerhe, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
 N/A Nov-12-2020 14:38:13 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mezgebe
Berhe Approved Nov-11-2020 16:47:49 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944316
Page 246 of 507
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
By my dated signature below, I, MezgebeBerhe, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
 N/A Nov-09-2020 08:31:53 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mezgebe
Berhe Approved Nov-07-2020 18:34:35 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MezgebeBerhe, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
 N/A Nov-06-2020 12:48:58 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944317
Page 247 of 507
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
N/A
Mezgebe
Berhe Approved Nov-06-2020 12:10:07 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MezgebeBerhe, 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-05-2020 08:14:18 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mezgebe
Berhe Approved Nov-04-2020 18:28:57 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944318
Page 248 of 507
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
By my dated signature below, I, MezgebeBerhe, 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.
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944319
Page 249 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-08-2020
11:54:51
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-08-2020
11:54:51
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944320
Page 250 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-08-2020
11:55:08
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent
Obtained
Sep/8/2020Initial Entry
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944321
Page 251 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-08-2020
11:54:44
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11701217Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-08-2020
11:54:41
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1963Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-08-2020
11:55:19
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-08-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944322
Page 252 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11:55:19
(UTC-06:00)
Central Time (US &
Canada)NOT HISPANIC OR LA
TINO(A) OR OF SPAN
ISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-08-2020
11:55:19
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944323
Page 253 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-08-2020
11:56:36
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944324
Page 254 of 507
***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: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-08-2020
11:56:54
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-08-2020
11:56:54
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-08-2020
11:56:54
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944325
Page 255 of 507
***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, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Jan-06-2021
10:36:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:1
Medical Hi
story Term
:Hyperte
nsion
Start Date: UNK/U
NK/199
8
Ongoing: YESTranscription
Error
Oct-23-2020
14:56:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:1
Medical Hi
story Term
:Hyperte
nsion
Start Date: UNK/U
NK/198
0
Ongoing: YESTranscription
Error
Oct-23-2020
10:22:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:1
Medical Hi
story Term
:Hyperte
nsionTranscription
Error
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944326
Page 256 of 507
***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, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Start Date: UNK/U
NK/199
8
Ongoing: YES
Sep-08-2020
11:57:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical Hi
story Term
:Hyperte
nsion
Start Date: UNK/U
NK/198
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-08-2020
11:57:30
(UTC-06:00)
Central 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
Sep-08-2020
11:57:30
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944327
Page 257 of 507
***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, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.a Start Date:
Date Location User Value Reason
Jan-06-2021
10:36:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Transcription
Error
Oct-23-2020
14:56:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Transcription
Error
Oct-23-2020
10:22:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Transcription
Error
Sep-08-2020
11:57:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-08-2020
11:57:30
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944328
Page 258 of 507
***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, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b
Date Location User Value Reason
Jan-06-2021
10:36:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/M
H Num
ber:2
Medica
l Histor
y Term:Chronic De
ep Vein Thr
ombosis (D
VT)
Start D
ate:UNK/UNK/
1980
Ongoin
g:YESTranscription
Error
Oct-23-2020
14:55:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/M
H Num
ber:2
Medica
l Histor
y Term:Chronic De
ep Vein Thr
ombosis (D
VT)
Start D
ate:UNK/UNK/
1998
Ongoin
g:YESTranscription
Error
Oct-23-2020
10:21:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/M
H Num
ber:2Transcription
Error
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944329
Page 259 of 507
***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, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Medica
l Histor
y Term:Chronic De
ep Vein Thr
ombosis (D
VT)
Start D
ate:UNK/UNK/
1980
Ongoin
g:YES
Oct-20-2020
07:31:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/M
H Num
ber:2
Medica
l Histor
y Term:Chronic De
ep Vein Thr
ombosis (D
VT)
Start D
ate:UNK/UNK/
1998
Ongoin
g:YESNew
Information
Sep-08-2020
11:57:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical Hi
story Term
:Blood C
lots
Start Date: UNK/U
NK/199
8
Ongoing: YESInitial Entry
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944330
Page 260 of 507
***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, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b Line/MH Number:
Date Location User Value Reason
Sep-08-2020
11:57:45
(UTC-06:00)
Central 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
Jan-07-2021
20:56:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 2: Closed Response
satisfies query
Jan-06-2021
10:33:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answered Data entered.
Jan-05-2021
09:38:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 2: Reissued:O
penedGPDClin:
Thank you! I
think MHx
module is
currently
open/unfrozen
and you should
be able to enter
data.
Jan-04-2021 ACV0PFEINFP6000  Query 2: Answered Monitor has
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944331
Page 261 of 507
***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, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
18:50:10
(UTC-06:00)
Central Time (US
& Canada)been contacted
to unlock
medical history
form. If you are
able to on your
end, please
unlock to update
data.
Dec-30-2020
13:09:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 2: Opened GPDClin: 1.
There are quite a
few MHx
reported in SAE
report are
missing here,
please add in. 2.
Per previous
queries, the
onset year for
HTN is 1980,
DVT is 1998
(correct here),
but are incorrect
in SAE report,
please submit
SAE FU report
for them.
Oct-20-2020
08:55:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response
satisfies query
Oct-20-2020
07:31:18ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New
Information
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944332
Page 262 of 507
***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, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00)
Central Time (US
& Canada)
Oct-20-2020
07:31:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Chronic Deep Vein T
hrombosis (DVT)New
Information
Oct-20-2020
00:47:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Reissued:O
penedThanks for the
response, form
has been
unfreeze, please
update as per
below query
Oct-19-2020
17:08:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Reissued:Ca
ndidateGPDClin:
Please unfreeze
MHx module, so
the site can
make change.
Oct-19-2020
14:11:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Yes, please
unfreeze form in
med hx to
update. Thank
you.
Oct-08-2020
14:49:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: In the
SAE report, the
MHx was
reported as
chronic deep
vein thrombosis.
If chronic DVT
is more
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944333
Page 263 of 507
***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, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
appropriate
term, please
make the change
here.
Sep-08-2020
11:57:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Blood ClotsInitial Entry
1.b Start Date:
Date Location User Value Reason
Jan-06-2021
10:36:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Transcription
Error
Oct-23-2020
16:50:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response
satisfies query
Oct-23-2020
14:55:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Oct-23-2020
14:55:56
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Transcription
Error
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944334
Page 264 of 507
***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, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada)
Oct-23-2020
14:28:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Reissued:Op
enedGPDClin: It is
unlikely that
DVT started 18
years earlier
than HTN and
diabetes. I
would think the
data previously
in InForm was
correct, i.e.,
HTN 1980,
diabetes and
DVT 1998, and
likely there was
error in SAE
report for HTN
and DVT dates.
Please check.
Oct-23-2020
10:21:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Oct-23-2020
10:21:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Transcription
Error
Oct-08-2020
15:11:06
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin:
Noticed a
mismatch vs.
SAE report in
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944335
Page 265 of 507
***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, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada) which DVT
started 1980 and
HTN started
1998. If the
information in
SAE report is
incorrect, please
submit a FU
SAE report to
correct it.
Sep-08-2020
11:57:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-08-2020
11:57:45
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-28-2020
08:05:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Type II
DiabetesNew
Information
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944336
Page 266 of 507
***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, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Start Date: UNK/U
NK/1998
Ongoing: YES
Sep-08-2020
11:58:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Diabetes
Start Date: UNK/U
NK/1998
Ongoing: YESInitial Entry
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944337
Page 267 of 507
***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, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.c Line/MH Number:
Date Location User Value Reason
Sep-08-2020
11:58:01
(UTC-06:00)
Central 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
Oct-28-2020
09:07:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-28-2020
08:05:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New
Information
Oct-28-2020
08:05:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type II DiabetesNew
Information
Oct-28-2020
04:44:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery:
Please specify
type of diabetes
(TYPE I or II,
for example)
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944338
Page 268 of 507
***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, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
and update
medical history
term as
applicable.
Oct-27-2020
16:45:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Candidate ClinQuery:
Please specify
type of diabetes
(TYPE I or II,
for example)
and update
medical history
term as
applicable.
Sep-08-2020
11:58:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
DiabetesInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-08-2020
11:58:01
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944339
Page 269 of 507
***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, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases
Consultants, P.A.
Subject No: 11701217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.c Ongoing:
Date Location User Value Reason
Sep-08-2020
11:58:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-28-2020
14:34:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/MH N
umber:4
Medical Hi
story Term
:Seasonal
Allergies
Start Date: UNK/U
NK/1963
Ongoing: YESTranscription
Error
Sep-08-2020
11:58:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical Hi
story Term
:Allergies
/Hayfeve
r
Start Date: UNK/U
NK/1963
Ongoing: YESInitial Entry
090177e196ae3f91\Final\Final On: 01-Apr-2021 05:19 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944340
Page 270 of 507
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
…[truncated]