Document text
Page 1 of 404
***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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907436
Page 2 of 404
***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: 10421034 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/4/2020
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907437
Page 3 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10421034]
2.Birth Date: 1982
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907438
Page 4 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/4/2020
2.Erroneous Visit
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907439
Page 5 of 404
***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: 10421034 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
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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907440
Page 6 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907441
Page 7 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907442
Page 8 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907443
Page 9 of 404
***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: 10421034 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:[Drug Allergy to Sulfa-Reaction (Hives)]
Start Date: UNK/UNK/2014
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Food Allergy to Peanuts]
Start Date: UNK/UNK/2012
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal Reflux]
Start Date: Mar/UNK/2020
Ongoing: YES
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907444
Page 10 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tonsillitis]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: Jul/UNK/2016
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Panic Attacks]
Start Date: Jul/UNK/2016
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tonsillectomy]
Start Date: UNK/UNK/2006
Ongoing: NO
End Date:
UNK/UNK/2006
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907445
Page 11 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/4/2020
2.Weight: [179.2]
3.Unit: LB
4.Height: [65.0]
5.Unit: in
6.Body Mass Index: [29.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907446
Page 12 of 404
***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: 10421034 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/4/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907447
Page 13 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/4/2020
2.Randomization Number: [41955]
3.Randomization Group: [ ]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907448
Page 14 of 404
***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: 10421034 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/4/2020
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 [BP3LZ9]
5.bSample ID [BP3LZB]
5.cSample ID [BP3LZC]
5.dSample ID [BPLCN4]
5.eSample ID [BPLCN5]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907449
Page 15 of 404
***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: 10421034 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/4/2020
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 [BP3M4L]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907450
Page 16 of 404
***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: 10421034 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/4/2020 12:21
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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907451
Page 17 of 404
***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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907452
Page 18 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907453
Page 19 of 404
***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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907454
Page 20 of 404
***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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907455
Page 21 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907456
Page 22 of 404
***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: 10421034 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/25/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907457
Page 23 of 404
***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: 10421034 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/25/2020
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 [BN5R7Y]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907458
Page 24 of 404
***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: 10421034 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/25/2020 10:43
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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907459
Page 25 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907460
Page 26 of 404
***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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907461
Page 27 of 404
***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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907462
Page 28 of 404
***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: 10421034 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/25/2020
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 [BPBYG3]
5.bSample ID [BPBYG4]
5.cSample ID [BPBYG5]
5.dSample ID [BKZDWK]
5.eSample ID [BKZDWL]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907463
Page 29 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907464
Page 30 of 404
***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: 10421034 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/24/2021
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 [BMZZ0F]
5.bSample ID [BL9NXC]
5.cSample ID [BL9NX9]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907465
Page 31 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907466
Page 32 of 404
***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: 10421034 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 [ ]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907467
Page 33 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907468
Page 34 of 404
***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: 10421034 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 [ ]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907469
Page 35 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907470
Page 36 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/16/2020
2.Date of First Symptom Started: Dec/16/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/20/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907471
Page 37 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Symptoms - Other
5.aSymptoms - Other Text: [New or increased nasal discharge]
5.bSymptoms - Other Text: [Headache]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907472
Page 38 of 404
***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: 10421034 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 Type Form Instance
1.Not Applicable Not Applicab
le Not Applicable Not Applicable Not Applicab
le Repeating
Pages
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907473
Page 39 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description: Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907474
Page 40 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 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
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Dec/16/2020
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 [CV29007]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907475
Page 41 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 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 collected] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907476
Page 42 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 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: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907477
Page 43 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Treatment Start Date Form Instance
1.Not Applicable Not Applicable Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907478
Page 44 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907479
Page 45 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 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?NO
3.Toxicity Grade: 1
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907480
Page 46 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1.Not Applicable Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907481
Page 47 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907482
Page 48 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
1.Not Applicable Not Applic
able 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907483
Page 49 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907484
Page 50 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907485
Page 51 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907486
Page 52 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907487
Page 53 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
1.Not Applicabl
e Not Applicable Not Applic
able Not Appli
cable Sponsor-Defined
IdentifierTest: Result:
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
Not Applicable Not Appli
cable Not Appli
cable
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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907488
Page 54 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907489
Page 55 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907490
Page 56 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907491
Page 57 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907492
Page 58 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907493
Page 59 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907494
Page 60 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable Not Applicable Not Applicable Repeating Pages
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907495
Page 61 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907496
Page 62 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable Not Applicable Repeating Pages
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907497
Page 63 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907498
Page 64 of 404
***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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907499
Page 65 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907500
Page 66 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
1.Not Applicable Not Applicable Not Applicable Not Applicable Not Applic
able Repeating
Pages
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907501
Page 67 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907502
Page 68 of 404
***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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907503
Page 69 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907504
Page 70 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/20/2021Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907505
Page 71 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/20/2021Form: 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: 10421034 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:
Jan/20/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BMZZ69]
5.bSample ID [BL9NSC]
5.cSample ID [BL9NSB]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907506
Page 72 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907507
Page 73 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907508
Page 74 of 404
***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: 10421034 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/25/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907509
Page 75 of 404
***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: 10421034 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: [ ]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907510
Page 76 of 404
***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: 10421034 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:
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907511
Page 77 of 404
***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: 10421034 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 [ ]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907512
Page 78 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identif
ierAdverse Ev
entStart DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 Acne Nov/UNK/2020 UNK:
UNK YES Repeating
Pages
2.ADVERSE EVE
NT 2 cholecystitis
Feb/7/2021 UNK:UNK
NO
End Date Time:
Feb/9/2021 UNK:UNK
Repeating
Pages
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907513
Page 79 of 404
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 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: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Acne]
4.Start Date Time: Nov/UNK/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Wearing a mask]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907514
Page 80 of 404
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907515
Page 81 of 404
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 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)[cholecystitis]
4.Start Date Time: Feb/7/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/9/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907516
Page 82 of 404
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 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:
[Gallbladder Infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021206864]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907517
Page 83 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
1. Repeating
Pages
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907518
Page 84 of 404
***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: 10421034 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[ ]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907519
Page 85 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907520
Page 86 of 404
***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: 10421034 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: //
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907521
Page 87 of 404
***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: 10421034 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
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907522
Page 88 of 404
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 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.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907523
Page 89 of 404
***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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907524
Page 90 of 404
***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: 10421034 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?
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907525
Page 91 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907526
Page 92 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907527
Page 93 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907528
Page 94 of 404
***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: 10421034 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:
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907529
Page 95 of 404
***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: 10421034 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:
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907530
Page 96 of 404
***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: 10421034 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?
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907531
Page 97 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907532
Page 98 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907533
Page 99 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907534
Page 100 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907535
Page 101 of 404
***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: 10421034 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 [ ]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907536
Page 102 of 404
***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: 10421034 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 [ ]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907537
Page 103 of 404
***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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907538
Page 104 of 404
***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: 10421034 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 and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907539
Page 105 of 404
***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: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907540
Page 106 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907541
Page 107 of 404
***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: 10421034 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: [ ]
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907542
Page 108 of 404
***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: 10421034 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/25/2020
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907543
Page 109 of 404
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 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
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907544
Page 110 of 404
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 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
Name Signature
MeaningDate Type Action
Approved Mar-09-2021 14:52:47 (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.
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907545
Page 111 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormDec-17-2020 09:27:15 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907546
Page 112 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Dec-17-2020 09:27:15 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907547
Page 113 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Dec-17-2020 09:27:15 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907548
Page 114 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Dec-17-2020 09:27:15 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907549
Page 115 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Dec-17-2020 09:27:15 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907550
Page 116 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Dec-17-2020 09:27:15 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907551
Page 117 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Dec-17-2020 09:27:15 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907552
Page 118 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Dec-17-2020 09:27:15 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907553
Page 119 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Dec-17-2020 09:27:15 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907554
Page 120 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Dec-17-2020 09:27:15 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907555
Page 121 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormDec-17-2020 09:29:57 (UTC-06:00) Central
Time (US & Canada)Awaiting sample results
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907556
Page 122 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormDec-18-2020 08:23:44 (UTC-06:00) Central
Time (US & Canada)
FormDec-18-2020 08:23:36 (UTC-06:00) Central
Time (US & Canada)Unknown
FormDec-18-2020 08:23:13 (UTC-06:00) Central
Time (US & Canada)Self swab done by subject
FormDec-17-2020 09:31:39 (UTC-06:00) Central
Time (US & Canada)Self swab done by subject
Not Applicable
090177e196ae3e44\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)
FDA-CBER-2021-5683-0907557
Page 123 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Dec-18-2020 08:23:44 (UTC-06:00) Central Time
(US & Canada)
1Dec-18-2020 08:23:36 (UTC-06:00) Central Time
(US & Canada)Unknown
1Dec-18-2020 08:23:13 (UTC-06:00) Central Time
(US & Canada)Self swab done by subject
1Dec-17-2020 09:31:39 (UTC-06:00) Central Time
(US & Canada)Self swab done by subject
Not Applicable
090177e196ae3e44\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)
FDA-CBER-2021-5683-0907558
Page 124 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Dec-18-2020 08:23:44 (UTC-06:00) Central Time
(US & Canada)
2Dec-18-2020 08:23:36 (UTC-06:00) Central Time
(US & Canada)Unknown
2Dec-18-2020 08:23:13 (UTC-06:00) Central Time
(US & Canada)Self swab done by subject
2Dec-17-2020 09:31:39 (UTC-06:00) Central Time
(US & Canada)Self swab done by subject
Not Applicable
090177e196ae3e44\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)
FDA-CBER-2021-5683-0907559
Page 125 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Dec-18-2020 08:23:44 (UTC-06:00) Central Time
(US & Canada)
3Dec-18-2020 08:23:36 (UTC-06:00) Central Time
(US & Canada)Unknown
3Dec-18-2020 08:23:13 (UTC-06:00) Central Time
(US & Canada)Self swab done by subject
3Dec-17-2020 09:31:39 (UTC-06:00) Central Time
(US & Canada)Self swab done by subject
Not Applicable
090177e196ae3e44\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)
FDA-CBER-2021-5683-0907560
Page 126 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Dec-18-2020 08:23:44 (UTC-06:00) Central Time
(US & Canada)
4Dec-18-2020 08:23:36 (UTC-06:00) Central Time
(US & Canada)Unknown
4Dec-18-2020 08:23:13 (UTC-06:00) Central Time
(US & Canada)Self swab done by subject
4Dec-17-2020 09:31:39 (UTC-06:00) Central Time
(US & Canada)Self swab done by subject
Not Applicable
090177e196ae3e44\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)
FDA-CBER-2021-5683-0907561
Page 127 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormDec-17-2020 09:44:30 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907562
Page 128 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Dec-17-2020 09:44:30 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907563
Page 129 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Dec-17-2020 09:44:30 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907564
Page 130 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Dec-17-2020 09:44:30 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907565
Page 131 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Dec-17-2020 09:44:30 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907566
Page 132 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Dec-17-2020 09:44:30 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907567
Page 133 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Dec-17-2020 09:44:30 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907568
Page 134 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormDec-17-2020 09:45:29 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907569
Page 135 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Dec-17-2020 09:45:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907570
Page 136 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Dec-17-2020 09:45:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907571
Page 137 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Dec-17-2020 09:45:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907572
Page 138 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Dec-17-2020 09:45:29 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907573
Page 139 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormDec-17-2020 09:45:50 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907574
Page 140 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Dec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907575
Page 141 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Dec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907576
Page 142 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Dec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907577
Page 143 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Dec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907578
Page 144 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.aDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907579
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907580
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907581
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bDec-17-2020 09:45:50 (UTC-06:00) Central Time
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090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bDec-17-2020 09:45:50 (UTC-06:00) Central Time
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090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907588
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907589
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907592
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907593
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907594
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eDec-17-2020 09:45:50 (UTC-06:00) Central Time
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090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907597
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eDec-17-2020 09:45:50 (UTC-06:00) Central Time
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090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0907598
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907599
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fDec-17-2020 09:45:50 (UTC-06:00) Central Time
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090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907600
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907601
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907602
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0907603
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
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(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0907604
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0907605
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gDec-17-2020 09:45:50 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907606
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormDec-17-2020 09:46:09 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907607
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Dec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907608
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Dec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907609
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Dec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907610
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Dec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907611
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907612
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907613
Page 179 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907614
Page 180 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907615
Page 181 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907616
Page 182 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907617
Page 183 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907618
Page 184 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907619
Page 185 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907620
Page 186 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907621
Page 187 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907622
Page 188 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907623
Page 189 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907624
Page 190 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907625
Page 191 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907626
Page 192 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907627
Page 193 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907628
Page 194 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907629
Page 195 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907630
Page 196 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907631
Page 197 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907632
Page 198 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907633
Page 199 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907634
Page 200 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907635
Page 201 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907636
Page 202 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907637
Page 203 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907638
Page 204 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907639
Page 205 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907640
Page 206 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907641
Page 207 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907642
Page 208 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/16/2020Form: 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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hDec-17-2020 09:46:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907643
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Site No: 1042 Site Name: (1042) HealthFirst Medical Group
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ItemDate User Comment
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***Confidential***
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Site No: 1042 Site Name: (1042) HealthFirst Medical Group
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ItemDate User Comment
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090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
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ItemDate User Comment
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(b) (4)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1042 Site Name: (1042) HealthFirst Medical Group
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ItemDate User Comment
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(b) (4), (b) (6)
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***Confidential***
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
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(b) (4)
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***Confidential***
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
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090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907650
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
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(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907651
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormDec-17-2020 09:46:27 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907652
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Dec-17-2020 09:46:27 (UTC-06:00) Central Time
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090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907653
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
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090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907654
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
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Back to Form
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090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907655
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10421034 Subject Initials: ---
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(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907656
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
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090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907657
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10421034 Subject Initials: ---
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Back to Form
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FormDec-17-2020 09:47:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907658
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10421034 Subject Initials: ---
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Back to Form
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(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0907659
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
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Back to Form
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FDA-CBER-2021-5683-0907660
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10421034 Subject Initials: ---
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Back to Form
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FormDec-17-2020 09:47:25 (UTC-06:00) Central
Time (US & Canada)Not Applicable
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0907661
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10421034 Subject Initials: ---
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Back to Form
ItemDate User Comment
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FDA-CBER-2021-5683-0907662
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10421034 Subject Initials: ---
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Back to Form
ItemDate User Comment
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FDA-CBER-2021-5683-0907663
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10421034 Subject Initials: ---
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Back to Form
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(b) (4)
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10421034 Subject Initials: ---
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Back to Form
ItemDate User Comment
FormDec-17-2020 09:49:51 (UTC-06:00) Central
Time (US & Canada)Not Applicable
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
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Subject No: 10421034 Subject Initials: ---
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Back to Form
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
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Subject No: 10421034 Subject Initials: ---
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Back to Form
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
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Subject No: 10421034 Subject Initials: ---
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Back to Form
ItemDate User Comment
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
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Subject No: 10421034 Subject Initials: ---
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Back to Form
ItemDate User Comment
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
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Subject No: 10421034 Subject Initials: ---
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FDA-CBER-2021-5683-0907670
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10421034 Subject Initials: ---
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Back to Form
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FDA-CBER-2021-5683-0907671
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10421034 Subject Initials: ---
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Back to Form
ItemDate User Comment
FormDec-17-2020 09:50:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
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FDA-CBER-2021-5683-0907672
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
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FDA-CBER-2021-5683-0907673
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Dec-17-2020 09:50:10 (UTC-06:00) Central Time
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FDA-CBER-2021-5683-0907674
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Dec-17-2020 09:50:10 (UTC-06:00) Central Time
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(b) (4), (b) (6)
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FDA-CBER-2021-5683-0907675
Page 241 of 404
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Dec-17-2020 09:50:10 (UTC-06:00) Central Time
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090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0907676
Page 242 of 404
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 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
Name Signature
MeaningDate Type Action
Approved Mar-09-2021 14:52:47 (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 Feb-25-2021 16:22:30 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 12:29:26 (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 Dec-17-2020 09:21:22 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-12-2020 10:41:11 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907677
Page 243 of 404
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 Sep-28-2020 15:59:38 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Sep-11-2020 15:42:37 (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.
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907678
Page 244 of 404
***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: 10421034 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-04-2020 15:22:09
(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-04-2020 15:22:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907679
Page 245 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-04-2020 15:22:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/4/2020Initial Entry
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907680
Page 246 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-04-2020 15:22:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10421034Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-04-2020 15:21:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1982Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-04-2020 15:25:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-04-2020 15:25:18
(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-04-2020 15:25:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e44\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-2021-5683-0907681
Page 247 of 404
***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: 10421034 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-04-2020 15:25:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020Initial Entry
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907682
Page 248 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Inclus
ion N
umber
:1
Criter
ion De
scripti
on:Male or female participant
s between the ages of 18 a
nd 55 years, inclusive, 65 a
nd 85 years, inclusive, or 1
8 and 85 years, inclusive, a
t randomization (dependen
t 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-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Male or female participants betwee
n the ages of 18 and 55 years, inclu
sive, 65 and 85 years, inclusive, or
18 and 85 years, inclusive, at rando
mization (dependent upon study sta
ge)Initial Entry
090177e196ae3e44\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-2021-5683-0907683
Page 249 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.a Criterion met?
Date Location User Value Reason
Aug-04-2020 15:26:23
(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-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-04-2020 15:26:23
(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 wit
h all scheduled visits, vacc
ination plan, laboratory tes
ts, lifestyle considerations,
and other study procedure
s
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN02A00Initial Entry
090177e196ae3e44\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-2021-5683-0907684
Page 250 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Inclusion Number:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Participants who are willing and abl
e to comply with all scheduled visit
s, vaccination plan, laboratory tests,
lifestyle considerations, and other st
udy proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-04-2020 15:26:23
(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-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae3e44\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-2021-5683-0907685
Page 251 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Criteri
on Des
criptio
n:Healthy participants who a
re determined by medical
history, physical examinati
on, and clinical judgment
of the investigator to be eli
gible for inclusion in the st
udy
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN03A00
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0907686
Page 252 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Inclusion Number:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Healthy participants who are deter
mined by medical history, physical
examination, and clinical judgment
of the investigator to be eligible for
inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-04-2020 15:26:23
(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-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4
Criteri
on Des
criptio
n:Capable of giving persona
l signed informed consent,
which includes complianc
e with the requirements an
d restrictions listed in the I
CD and in this protocolInitial Entry
090177e196ae3e44\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-2021-5683-0907687
Page 253 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer us
e only)
:IN04A00
1.d Inclusion Number:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Capable of giving personal signed i
nformed consent, which includes co
mpliance with the requirements and
restrictions listed in the ICD and in
this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-04-2020 15:26:23
(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-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
090177e196ae3e44\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)
FDA-CBER-2021-5683-0907688
Page 254 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:1
Criteri
on Des
criptio
n:Other medical or psychiatr
ic condition incl. recent (w
ithin past year) or active s
uicidal ideation/behavior/l
ab abnormality that may in
crease the risk of study par
ticipation
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX01A00Initial Entry
2.a Exclusion Number:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Other medical or psychiatric conditi
on incl. recent (within past year) or
active suicidal ideation/behavior/la
b abnormality that may increase the
risk of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e44\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)
FDA-CBER-2021-5683-0907689
Page 255 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:2
Criterio
n Descri
ption:Known infection with hu
man immunodeficiency
virus (HIV), hepatitis C
virus (HCV), or hepatitis
B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only
):EX02A00Initial Entry
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907690
Page 256 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.b Exclusion Number:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Known infection with human immu
nodeficiency virus (HIV), hepatitis
C virus (HCV), or hepatitis B virus
(HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-04-2020 15:26:23
(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-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Des
criptio
n:History of severe adverse
reaction associated with a
vaccine and/or severe aller
gic reaction (eg, anaphyla
xis) to any component of t
he study intervention(s)Initial Entry
090177e196ae3e44\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-2021-5683-0907691
Page 257 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX03A00
2.c Exclusion Number:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
History of severe adverse reaction a
ssociated with a vaccine and/or sev
ere allergic reaction (eg, anaphylaxi
s) to any component of the study int
ervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-04-2020 15:26:23
(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-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
090177e196ae3e44\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)
FDA-CBER-2021-5683-0907692
Page 258 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:4
Criterion De
scription:Receipt of medicati
ons intended to pre
vent COVID-19
Criterion me
t?:NO
Criterion ID:
(For Pfizer u
se only):EX04A00Initial Entry
2.d Exclusion Number:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-04-2020 15:26:23
(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-04-2020 15:26:23
(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-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
090177e196ae3e44\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-2021-5683-0907693
Page 259 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:8
Criteri
on Des
criptio
n:Immunocompromised ind
ividuals with known or su
spected immunodeficienc
y, as determined by histor
y and/or laboratory/physic
al examination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX08A00Initial Entry
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907694
Page 260 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.e Exclusion Number:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Immunocompromised individuals
with known or suspected immunod
eficiency, as determined by history
and/or laboratory/physical examinat
ionInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-04-2020 15:26:23
(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-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:10
Criteri
on Des
criptio
n:Bleeding diathesis or cond
ition associated with prolo
nged bleeding that would,
in the opinion of the inves
tigator, contraindicate intr
amuscular injectionInitial Entry
090177e196ae3e44\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-2021-5683-0907695
Page 261 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition asso
ciated with prolonged bleeding that
would, in the opinion of the investi
gator, contraindicate intramuscular
injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-04-2020 15:26:23
(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-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
090177e196ae3e44\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)
FDA-CBER-2021-5683-0907696
Page 262 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:11
Criterion Desc
ription:Women who are p
regnant or breastf
eeding
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX11A00Initial Entry
2.g Exclusion Number:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Women who are pregnant or breastf
eedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-04-2020 15:26:23
(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-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
090177e196ae3e44\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-2021-5683-0907697
Page 263 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:12
Criterion Des
cription:Previous vaccinati
on with any corona
virus vaccine
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX12A00Initial Entry
2.h Exclusion Number:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Previous vaccination with any coro
navirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-04-2020 15:26:23
(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-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
090177e196ae3e44\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-2021-5683-0907698
Page 264 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:13
Criterion
Descripti
on:Subjects who receive im
munosuppressive therap
y, such as cytotoxic age
nts or systemic corticost
eroids
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX13A01Initial Entry
2.i Exclusion Number:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Subjects who receive immunosuppr
essive therapy, such as cytotoxic ag
ents or systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
090177e196ae3e44\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-2021-5683-0907699
Page 265 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.j
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:15
Criteri
on Des
criptio
n:Receipt of blood/plasma p
roducts or immunoglobuli
n, from 60 days before stu
dy intervention administra
tion or planned receipt thr
oughout the study
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX14A01Initial Entry
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0907700
Page 266 of 404
***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: 10421034 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.j Exclusion Number:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma products o
r immunoglobulin, from 60 days be
fore study intervention administrati
on or planned receipt throughout th
e studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 15:26:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae3e44\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
…[truncated]