125742 S1 M5 CRF c4591001 1042 10421023

Document text

Page 1 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906967
Page 2 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/3/2020
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906968
Page 3 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10421023]
2.Birth Date: /1959
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0906969
Page 4 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/3/2020
2.Erroneous Visit
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906970
Page 5 of 469
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for inclusion
in the study
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance
with the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN04A00
Exclusion Criteria
2.aExclusion Number: 1
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906971
Page 6 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX08A00
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906972
Page 7 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would, in
the opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX11A00
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX14A01
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906973
Page 8 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing
lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX21A01
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906974
Page 9 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906975
Page 10 of 469
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tonsillitis]
Start Date: UNK/UNK/1982
Ongoing: NO
End Date:
UNK/UNK/1982
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Post-Menopausal]
Start Date: Jan/UNK/2020
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Uterine Fibroids]
Start Date: Jan/UNK/2000
Ongoing: NO
End Date:
Jan/UNK/2000
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2006
Ongoing: YES
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906976
Page 11 of 469
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/3/2020
2.Weight: [182.6]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [31.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906977
Page 12 of 469
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/3/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906978
Page 13 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/3/2020
2.Randomization Number: [221202]
3.Randomization Group: [ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906979
Page 14 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/3/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3LY9]
5.bSample ID [BP3LYB]
5.cSample ID [BP3LYC]
5.dSample ID [BPLCMG]
5.eSample ID [BPLCMH]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906980
Page 15 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/3/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3M47]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906981
Page 16 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/3/2020 12:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906982
Page 17 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906983
Page 18 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906984
Page 19 of 469
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906985
Page 20 of 469
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906986
Page 21 of 469
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906987
Page 22 of 469
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/24/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906988
Page 23 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN5R7T]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906989
Page 24 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/24/2020 17:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906990
Page 25 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906991
Page 26 of 469
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906992
Page 27 of 469
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906993
Page 28 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/21/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN5R3R]
5.bSample ID [BN5R3S]
5.cSample ID [BN5R3T]
5.dSample ID [BPLD31]
5.eSample ID [BPLD32]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906994
Page 29 of 469
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906995
Page 30 of 469
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Samples collected under Convalescent Visit]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [ ]
5.bSample ID [ ]
5.cSample ID [ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906996
Page 31 of 469
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906997
Page 32 of 469
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906998
Page 33 of 469
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0906999
Page 34 of 469
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907000
Page 35 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907001
Page 36 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/28/2021
2.Date of First Symptom Started: Jan/23/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/3/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907002
Page 37 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Symptoms - Other
5.aSymptoms - Other Text: [ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907003
Page 38 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907004
Page 39 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907005
Page 40 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Jan/28/2021
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 [CV29000]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907006
Page 41 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB Comments
3.Sample Collected? NO Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[not done] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907007
Page 42 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: YES
Number of Visits or Contacts:
[1]
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]
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
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907008
Page 43 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907009
Page 44 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907010
Page 45 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?YES
Respiratory Illness Diagnosis:
[Covid-19]
Date of Diagnosis:
Jan/25/2021
3.Toxicity Grade: 4
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907011
Page 46 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907012
Page 47 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907013
Page 48 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable
 Not Appli
cable Not Applic
able Not Applic
able Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907014
Page 49 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907015
Page 50 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907016
Page 51 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907017
Page 52 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907018
Page 53 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907019
Page 54 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907020
Page 55 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907021
Page 56 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907022
Page 57 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907023
Page 58 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907024
Page 59 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907025
Page 60 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Jan/25/2021 Record Identifier: Systolic: Diastolic:
1  181  91 Repeating Pages
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907026
Page 61 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/25/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [181]
Diastolic: [91]
Respiratory Rate in
respirations/minute:[18]
Heart Rate in beats/minute: [99]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907027
Page 62 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Jan/25/2021 Record Identifier: Oxygen Saturation
1  96.0 Repeating Pages
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907028
Page 63 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/25/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [96.0]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907029
Page 64 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907030
Page 65 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907031
Page 66 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907032
Page 67 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907033
Page 68 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907034
Page 69 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907035
Page 70 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/25/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907036
Page 71 of 469
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/25/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
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 [BRLT4W]
5.bSample ID [BL9NY6]
5.cSample ID [BL9NY7]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907037
Page 72 of 469
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907038
Page 73 of 469
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907039
Page 74 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Sep/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907040
Page 75 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907041
Page 76 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907042
Page 77 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907043
Page 78 of 469
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instanc
e
 1. DELETED           Repeating
Pages
 2. ADVERSE E
VENT 2  Adenocarcinoma o
f the lung Jan/15/2021 UN
K:UNK YES  Repeating
Pages
 3. DELETED           Repeating
Pages
 4. DELETED           Repeating
Pages
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907044
Page 79 of 469
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
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).
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with Study
Treatment:
11.Was a Concomitant Medication
given?
12.Was a Non-Drug Treatment given?
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907045
Page 80 of 469
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
13.What was the outcome of this
adverse event?:
14.Did the adverse event cause the
subject to be discontinued from the
study?
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907046
Page 81 of 469
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Adenocarcinoma of the lung]
4.Start Date Time: Jan/15/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907047
Page 82 of 469
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[smoking - medical history]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021116949]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907048
Page 83 of 469
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
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).
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with Study
Treatment:
11.Was a Concomitant Medication
given?
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907049
Page 84 of 469
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
12.Was a Non-Drug Treatment given?
13.What was the outcome of this
adverse event?:
14.Did the adverse event cause the
subject to be discontinued from the
study?
15.Serious Adverse Event Number:
For Pfizer Use Only[2021116949 ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907050
Page 85 of 469
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
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).
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with Study
Treatment:
11.Was a Concomitant Medication
given?
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907051
Page 86 of 469
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
12.Was a Non-Drug Treatment given?
13.What was the outcome of this
adverse event?:
14.Did the adverse event cause the
subject to be discontinued from the
study?
15.Serious Adverse Event Number:
For Pfizer Use Only[2021116949 ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907052
Page 87 of 469
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907053
Page 88 of 469
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907054
Page 89 of 469
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907055
Page 90 of 469
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907056
Page 91 of 469
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defi
ned Identifie
rCategory for MedicationConcomitant Medi
cations Pre-specifie
dName of
Medicatio
nDose De
scriptionForm Instan
ce
 1. DELETED   CONCOMITANT IMMUN
OSUPPRESSIVE THERAP
Y     25  Repeating
Pages
 2. DELETED   CONCOMITANT IMMUN
OSUPPRESSIVE THERAP
Y     50  Repeating
Pages
 3. DELETED   CONCOMITANT IMMUN
OSUPPRESSIVE THERAP
Y     2.5  Repeating
Pages
 4. DELETED   CONCOMITANT IMMUN
OSUPPRESSIVE THERAP
Y     1  Repeating
Pages
 5. 5  IMMUNOGLOBULINS  NO  bamlanivi
mab 700  Repeating
Pages
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907057
Page 92 of 469
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category: CONCOMITANT IMMUNOSUPPRESSIVE THERAPY
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: [25]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: UNK/UNK/2012
10.Ongoing? YES
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907058
Page 93 of 469
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category: CONCOMITANT IMMUNOSUPPRESSIVE THERAPY
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: [50]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: UNK/UNK/2011
10.Ongoing? YES
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907059
Page 94 of 469
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category: CONCOMITANT IMMUNOSUPPRESSIVE THERAPY
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: [2.5]
6.Dose Unit: mg
7.Dose Frequency: QD
8.Route: ORAL
9.Start Date: UNK/UNK/2011
10.Ongoing? YES
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907060
Page 95 of 469
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category: CONCOMITANT IMMUNOSUPPRESSIVE THERAPY
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: [1]
6.Dose Unit: mg
7.Dose Frequency: BID
8.Route: ORAL
9.Start Date: Jun/2/2020
10.Ongoing? YES
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907061
Page 96 of 469
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [5]
2.Category: IMMUNOGLOBULINS
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).[bamlanivimab]
5.Dose: [700]
6.Dose Unit: mg
7.Dose Frequency: ONCE
8.Route: INTRAVENOUS
9.Start Date: Jan/25/2021
10.Ongoing? NO
End Date:
Jan/25/2021
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907062
Page 97 of 469
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907063
Page 98 of 469
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907064
Page 99 of 469
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907065
Page 100 of 469
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907066
Page 101 of 469
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907067
Page 102 of 469
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907068
Page 103 of 469
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907069
Page 104 of 469
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907070
Page 105 of 469
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907071
Page 106 of 469
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907072
Page 107 of 469
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907073
Page 108 of 469
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907074
Page 109 of 469
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907075
Page 110 of 469
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907076
Page 111 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907077
Page 112 of 469
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907078
Page 113 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907079
Page 114 of 469
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907080
Page 115 of 469
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907081
Page 116 of 469
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907082
Page 117 of 469
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907083
Page 118 of 469
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907084
Page 119 of 469
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907085
Page 120 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/21/2020
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907086
Page 121 of 469
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907087
Page 122 of 469
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907088
Page 123 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-01-2021 15:04:29 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907089
Page 124 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-01-2021 15:04:29 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907090
Page 125 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-01-2021 15:04:29 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907091
Page 126 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-01-2021 15:04:29 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907092
Page 127 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-01-2021 15:04:29 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907093
Page 128 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Feb-01-2021 15:04:29 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907094
Page 129 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Feb-01-2021 15:04:29 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907095
Page 130 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Feb-01-2021 15:04:29 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907096
Page 131 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Feb-01-2021 15:04:29 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907097
Page 132 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Feb-01-2021 15:04:29 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907098
Page 133 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-01-2021 08:19:48 (UTC-06:00) Central
Time (US & Canada)Self Swab done.
FormJan-29-2021 13:20:49 (UTC-06:00) Central
Time (US & Canada)Self Swab done.
Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907099
Page 134 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-01-2021 08:19:48 (UTC-06:00) Central
Time (US & Canada)Self Swab done.
1Jan-29-2021 13:20:49 (UTC-06:00) Central Time
(US & Canada)Self Swab done.
Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907100
Page 135 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-01-2021 08:19:48 (UTC-06:00) Central
Time (US & Canada)Self Swab done.
2Jan-29-2021 13:20:49 (UTC-06:00) Central Time
(US & Canada)Self Swab done.
Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907101
Page 136 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-01-2021 08:19:48 (UTC-06:00) Central
Time (US & Canada)Self Swab done.
3Jan-29-2021 13:20:49 (UTC-06:00) Central Time
(US & Canada)Self Swab done.
Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907102
Page 137 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-01-2021 08:19:48 (UTC-06:00) Central
Time (US & Canada)Self Swab done.
4Jan-29-2021 13:20:49 (UTC-06:00) Central Time
(US & Canada)Self Swab done.
Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907103
Page 138 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-29-2021 13:21:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907104
Page 139 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-29-2021 13:21:36 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907105
Page 140 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-29-2021 13:21:36 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907106
Page 141 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-29-2021 13:21:36 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907107
Page 142 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-29-2021 13:21:36 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907108
Page 143 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Jan-29-2021 13:21:36 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907109
Page 144 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Jan-29-2021 13:21:36 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907110
Page 145 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-29-2021 13:22:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907111
Page 146 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-29-2021 13:22:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907112
Page 147 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-29-2021 13:22:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907113
Page 148 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-29-2021 13:22:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907114
Page 149 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-29-2021 13:22:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907115
Page 150 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-29-2021 13:22:58 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907116
Page 151 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907117
Page 152 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907118
Page 153 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907119
Page 154 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907120
Page 155 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907121
Page 156 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907122
Page 157 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907123
Page 158 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907124
Page 159 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907125
Page 160 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907126
Page 161 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907127
Page 162 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907128
Page 163 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907129
Page 164 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907130
Page 165 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907131
Page 166 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907132
Page 167 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907133
Page 168 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907134
Page 169 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907135
Page 170 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907136
Page 171 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907137
Page 172 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907138
Page 173 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907139
Page 174 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907140
Page 175 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907141
Page 176 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907142
Page 177 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907143
Page 178 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907144
Page 179 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907145
Page 180 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907146
Page 181 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907147
Page 182 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-29-2021 13:22:58 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907148
Page 183 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-29-2021 13:24:14 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907149
Page 184 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907150
Page 185 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907151
Page 186 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907152
Page 187 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907153
Page 188 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907154
Page 189 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907155
Page 190 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907156
Page 191 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907157
Page 192 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907158
Page 193 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907159
Page 194 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907160
Page 195 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907161
Page 196 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907162
Page 197 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907163
Page 198 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907164
Page 199 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907165
Page 200 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907166
Page 201 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907167
Page 202 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907168
Page 203 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907169
Page 204 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907170
Page 205 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907171
Page 206 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907172
Page 207 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907173
Page 208 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907174
Page 209 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907175
Page 210 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907176
Page 211 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907177
Page 212 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907178
Page 213 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907179
Page 214 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907180
Page 215 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907181
Page 216 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907182
Page 217 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907183
Page 218 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907184
Page 219 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907185
Page 220 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907186
Page 221 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907187
Page 222 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907188
Page 223 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907189
Page 224 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907190
Page 225 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907191
Page 226 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907192
Page 227 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jJan-29-2021 13:24:14 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907193
Page 228 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-29-2021 13:27:08 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907194
Page 229 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-29-2021 13:27:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907195
Page 230 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-29-2021 13:27:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907196
Page 231 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-29-2021 13:27:08 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907197
Page 232 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-29-2021 13:27:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907198
Page 233 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-29-2021 13:27:28 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907199
Page 234 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-29-2021 13:27:28 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907200
Page 235 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-29-2021 13:27:28 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907201
Page 236 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-29-2021 13:27:28 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907202
Page 237 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Jan-29-2021 13:27:28 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907203
Page 238 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Jan-29-2021 13:27:28 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907204
Page 239 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-29-2021 13:27:48 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907205
Page 240 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-29-2021 13:27:48 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907206
Page 241 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-29-2021 13:27:48 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907207
Page 242 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-29-2021 13:27:48 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907208
Page 243 of 469
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/28/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-29-2021 13:27:48 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907209
Page 244 of 469
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Mar-11-2021 11:54:16 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-09-2021 14:46:45 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-29-2021 12:34:39 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-12-2020 10:36:33 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907210
Page 245 of 469
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
 N/A Sep-21-2020 16:21:37 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Sep-11-2020 15:37:36 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907211
Page 246 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-03-2020 15:09:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-03-2020 15:09:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907212
Page 247 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-03-2020 15:09:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/3/2020Initial Entry
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907213
Page 248 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-03-2020 15:09:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10421023Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-03-2020 15:09:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1959Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-03-2020 15:10:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-03-2020 15:10:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-03-2020 15:10:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLACK OR AFRICAN AMERIC
ANInitial Entry
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907214
Page 249 of 469
***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: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-03-2020 15:11:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/3/2020Initial Entry
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907215
Page 250 of 469
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion De
scripti
on:Male or female participan
ts between the ages of 18
and 55 years, inclusive, 6
5 and 85 years, inclusive,
or 18 and 85 years, inclusi
ve, at randomization (dep
endent upon study stage)
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Male or female participants betwe
en the ages of 18 and 55 years, inc
lusive, 65 and 85 years, inclusive,
or 18 and 85 years, inclusive, at raInitial Entry
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907216
Page 251 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
ndomization (dependent upon stud
y stage)
1.a Criterion met?
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are willi
ng and able to comply wi
th all scheduled visits, va
ccination plan, laboratory
tests, lifestyle considerati
ons, and other study proc
edures
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN02A00Initial Entry
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907217
Page 252 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Inclusion Number:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participants who are willing and a
ble to comply with all scheduled v
isits, vaccination plan, laboratory t
ests, lifestyle considerations, and o
ther study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0907218
Page 253 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Criteri
on Des
criptio
n:Healthy participants who
are determined by medica
l history, physical examin
ation, and clinical judgme
nt of the investigator to b
e eligible for inclusion in
the study
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN03A00
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907219
Page 254 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Inclusion Number:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Healthy participants who are deter
mined by medical history, physical
examination, and clinical judgmen
t of the investigator to be eligible f
or inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0907220
Page 255 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Criteri
on Des
criptio
n:Capable of giving person
al signed informed conse
nt, which includes compli
ance with the requiremen
ts and restrictions listed i
n the ICD and in this prot
ocol
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN04A00
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907221
Page 256 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Inclusion Number:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Capable of giving personal signed
informed consent, which includes
compliance with the requirements
and restrictions listed in the ICD a
nd in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:1Initial Entry
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0907222
Page 257 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Criter
ion De
scripti
on:Other medical or psychiat
ric condition incl. recent (
within past year) or active
suicidal ideation/behavior
/lab abnormality that may
increase the risk of study
participation
Criter
ion me
t?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Other medical or psychiatric condi
tion incl. recent (within past year)
or active suicidal ideation/behavio
r/lab abnormality that may increas
e the risk of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907223
Page 258 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with h
uman immunodeficienc
y virus (HIV), hepatitis
C virus (HCV), or hepat
itis B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX02A00Initial Entry
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907224
Page 259 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.b Exclusion Number:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Known infection with human imm
unodeficiency virus (HIV), hepatit
is C virus (HCV), or hepatitis B vi
rus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0907225
Page 260 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Criteri
on Des
criptio
n:History of severe adverse
reaction associated with a
vaccine and/or severe alle
rgic reaction (eg, anaphyl
axis) to any component o
f the study intervention(s
)
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX03A00
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907226
Page 261 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.c Exclusion Number:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
History of severe adverse reaction
associated with a vaccine and/or se
vere allergic reaction (eg, anaphyl
axis) to any component of the stud
y intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion N
umber:4
Criterion De
scription:Receipt of medicati
ons intended to pre
vent COVID-19
Criterion me
t?:NOInitial Entry
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0907227
Page 262 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Criterion ID
: (For Pfizer
use only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Receipt of medications intended to
prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:8Initial Entry
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0907228
Page 263 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Criteri
on Des
criptio
n:Immunocompromised in
dividuals with known or
suspected immunodeficie
ncy, as determined by his
tory and/or laboratory/ph
ysical examination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX08A00
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907229
Page 264 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.e Exclusion Number:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Immunocompromised individuals
with known or suspected immuno
deficiency, as determined by histor
y and/or laboratory/physical exami
nationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0907230
Page 265 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Criteri
on Des
criptio
n:Bleeding diathesis or con
dition associated with pro
longed bleeding that wou
ld, in the opinion of the i
nvestigator, contraindicat
e intramuscular injection
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX10A00
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907231
Page 266 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.f Exclusion Number:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition ass
ociated with prolonged bleeding th
at would, in the opinion of the inv
estigator, contraindicate intramusc
ular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:11
Criterion Desc
ription:Women who are
pregnant or breas
tfeeding
Criterion met
?:NOInitial Entry
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0907232
Page 267 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Criterion ID: (
For Pfizer use
only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Women who are pregnant or breast
feedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinati
on with any coron
avirus vaccineInitial Entry
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0907233
Page 268 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Previous vaccination with any cor
onavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-03-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:13Initial Entry
090177e196ae3e45\Final\Final On: 01-Apr-2021 04:50 (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-2021-5683-0907234
Page 269 of 469
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version
…[truncated]