125742 S1 M5 CRF c4591001 1042 10421217

Document text

Page 1 of 672
***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: 10421217 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
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908194
Page 2 of 672
***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: 10421217 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
Sep/10/2020
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908195
Page 3 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10421217]
2.Birth Date: 1990
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:
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0908196
Page 4 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908197
Page 5 of 672
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908198
Page 6 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908199
Page 7 of 672
***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: 10421217 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:[Medication Allergy (Trileptal)]
Start Date: UNK/UNK/2016
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/1992
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Food Allergy (Milk)]
Start Date: UNK/UNK/1998
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Blood Clots (Thrombus)]
Start Date: Apr/UNK/2019
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Peptic Ulcer]
Start Date: UNK/UNK/2009
Ongoing: YES
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908200
Page 8 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/1993
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Attention Deficit Disorder]
Start Date: UNK/UNK/2012
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: UNK/UNK/2005
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: UNK/UNK/2001
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bipolar Disorder Type II]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908201
Page 9 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteonecrosis of the Knee [L]]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
Feb/19/2020
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Migraines]
Start Date: UNK/UNK/2012
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Eczema]
Start Date: UNK/UNK/1991
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Knee Pain [L]]
Start Date: UNK/UNK/2018
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Core Decompression [L] Knee]
Start Date: Feb/19/2019
Ongoing: NO
End Date:
Feb/19/2019
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908202
Page 10 of 672
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
2.Weight: [158.0]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [24.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908203
Page 11 of 672
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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: Sep/10/2020
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:
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908204
Page 12 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/10/2020
2.Randomization Number: [85789]
3.Randomization Group: [ ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908205
Page 13 of 672
***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: 10421217 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/10/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN5RGR]
5.bSample ID [BN5RGS]
5.cSample ID [BN5RGT]
5.dSample ID [BPLD0Z]
5.eSample ID [BPLD10]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908206
Page 14 of 672
***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: 10421217 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:
Sep/10/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN5RGB]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908207
Page 15 of 672
***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: 10421217 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: Sep/10/2020 11:16
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908208
Page 16 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908209
Page 17 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/29/2020
2.Erroneous Visit
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908210
Page 18 of 672
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908211
Page 19 of 672
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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: Sep/29/2020
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:
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908212
Page 20 of 672
***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: 10421217 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:
Sep/29/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN5PXR]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908213
Page 21 of 672
***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: 10421217 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: Sep/29/2020 16:48
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908214
Page 22 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908215
Page 23 of 672
***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: 10421217 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:
Oct/27/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRD7R3]
5.bSample ID [BRD7R4]
5.cSample ID [BRD7R5]
5.dSample ID [BKZF0S]
5.eSample ID [BKZF0T]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908216
Page 24 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908217
Page 25 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/27/2020
2.Date of First Symptom Started: Oct/27/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/11/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [fatigue]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908218
Page 26 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSymptoms - Other Text: [chest congestion]
5.cSymptoms - Other Text: [New or increased nasal discharge]
5.dSymptoms - Other Text: [Nausea]
5.eSymptoms - Other Text: [Headache]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908219
Page 27 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Co
llectionSpecimen Typ
eSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
 1.Not Applic
able Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating
Pages
 2.Nov/26/20
20 SWABBED M
ATERIAL NASOPHARYNX  SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAG
NOSTIC TEST Repeating
Pages
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908220
Page 28 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908221
Page 29 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/26/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [Antigen Quick Test CLIA certified]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908222
Page 30 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV52472]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908223
Page 31 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: 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: 10421217 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? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[self swab at home]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908224
Page 32 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Not Complete
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[3]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908225
Page 33 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicabl
e Not Applicabl
e Not Applicabl
e Repeating
Pages
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908226
Page 34 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908227
Page 35 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908228
Page 36 of 672
***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: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908229
Page 37 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908230
Page 38 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for La
b TestVendor Na
meCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable  Not Applic
able Not Applica
ble Not Applic
able Sponsor-Defined I
dentifierTest: Result:
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able Repeating
Pages
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908231
Page 39 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908232
Page 40 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908233
Page 41 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908234
Page 42 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908235
Page 43 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable  Not Applicable  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 
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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908236
Page 44 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908237
Page 45 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908238
Page 46 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908239
Page 47 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908240
Page 48 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908241
Page 49 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908242
Page 50 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908243
Page 51 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908244
Page 52 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908245
Page 53 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908246
Page 54 of 672
***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: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908247
Page 55 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908248
Page 56 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908249
Page 57 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908250
Page 58 of 672
***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: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908251
Page 59 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908252
Page 60 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/30/2020 Comments
2.Erroneous Visit ERRONEOUS VISIT Comments
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908253
Page 61 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Not Applicable
//Comments
2.Date of First Symptom Started: Not Applicable
//Comments
3.Symptoms Ongoing? Not Applicable Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? Not Applicable Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? Not Applicable Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? Not Applicable Comments
4.dSymptoms: CHILLS
Was symptom present? Not Applicable Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? Not Applicable Comments
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? Not Applicable Comments
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? Not Applicable Comments
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908254
Page 62 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.hSymptoms: DIARRHEA
Was symptom present? Not Applicable Comments
4.iSymptoms: VOMITING
Was symptom present? Not Applicable Comments
Symptoms - Other
5.aSymptoms - Other Text: [ ]
5.bSymptoms - Other Text: [ ]
5.cSymptoms - Other Text: [ ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908255
Page 63 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Locat
ionAssay Code and Descripti
onDevice Type Form Instance
 1.Not Applicable  Not Applicabl
e Not Applicable  Not Applicable  Not Applicabl
e Repeating
Pages
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908256
Page 64 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Not 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908257
Page 65 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID Not Applicable
[ ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908258
Page 66 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID Not Applicable
[ ]Comments
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908259
Page 67 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: Not Applicable Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: Not Applicable Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: Not Applicable Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: Not Applicable Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: Not Applicable Comments
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: Not Applicable Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: Not Applicable
[ ]Comments
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?Not Applicable Comments
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908260
Page 68 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908261
Page 69 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: 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: 10421217 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 Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908262
Page 70 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Was a diagnosis obtained for Potential
COVID-19 Illness?Not Applicable Comments
3.Toxicity Grade: Not Applicable Comments
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908263
Page 71 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908264
Page 72 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: 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: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908265
Page 73 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for La
b TestVendor Na
meCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable  Not Applic
able Not Applica
ble Not Applic
able Sponsor-Defined I
dentifierTest: Result:
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able 
Not Applicable  Not Applic
able Not Applic
able Repeating
Pages
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908266
Page 74 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908267
Page 75 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908268
Page 76 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908269
Page 77 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908270
Page 78 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable  Not Applicable  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 
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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908271
Page 79 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908272
Page 80 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908273
Page 81 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908274
Page 82 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908275
Page 83 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908276
Page 84 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908277
Page 85 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908278
Page 86 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908279
Page 87 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908280
Page 88 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908281
Page 89 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908282
Page 90 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: 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: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908283
Page 91 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908284
Page 92 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: 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: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908285
Page 93 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908286
Page 94 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908287
Page 95 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/30/2020Form: 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/30/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908288
Page 96 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Nov/30/2020Form: 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: 10421217 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:
Nov/30/2020
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 [BRD7WT]
5.bSample ID [BKZF43]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908289
Page 97 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908290
Page 98 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908291
Page 99 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/27/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908292
Page 100 of 672
***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: 10421217 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: [ ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908293
Page 101 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB 1 -
Unscheduled Visit on Nov/30/2020Form: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/30/2020
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab: COVID_AR1
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908294
Page 102 of 672
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB 1 -
Unscheduled Visit on Nov/30/2020Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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:
Nov/30/2020
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 [BN5CX6]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908295
Page 103 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
 1.ADVERSE EVE
NT 1  Exposure During Pregna
ncy Feb/10/2021 16:
22 YES  Repeating
Pages
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908296
Page 104 of 672
***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: 10421217 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)[Exposure During Pregnancy]
4.Start Date Time: Feb/10/2021 16:22
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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:
[n/a]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908297
Page 105 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908298
Page 106 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908299
Page 107 of 672
***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: 10421217 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[ ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908300
Page 108 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908301
Page 109 of 672
***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: 10421217 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: //
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908302
Page 110 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908303
Page 111 of 672
***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: 10421217 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?
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908304
Page 112 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908305
Page 113 of 672
***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: 10421217 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?
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908306
Page 114 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908307
Page 115 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908308
Page 116 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908309
Page 117 of 672
***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: 10421217 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:
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908310
Page 118 of 672
***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: 10421217 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:
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908311
Page 119 of 672
***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: 10421217 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?
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908312
Page 120 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908313
Page 121 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908314
Page 122 of 672
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908315
Page 123 of 672
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908316
Page 124 of 672
***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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/15/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908317
Page 125 of 672
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908318
Page 126 of 672
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908319
Page 127 of 672
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908320
Page 128 of 672
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/18/2021
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908321
Page 129 of 672
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908322
Page 130 of 672
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/18/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908323
Page 131 of 672
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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: Jan/18/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908324
Page 132 of 672
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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/18/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRD7YV]
5.bSample ID [BL9NS0]
5.cSample ID [BL9NS1]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908325
Page 133 of 672
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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:
Jan/18/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMXPZ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908326
Page 134 of 672
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/18/2021 11:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908327
Page 135 of 672
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908328
Page 136 of 672
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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: Feb/10/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908329
Page 137 of 672
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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:
Feb/10/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRD81P]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908330
Page 138 of 672
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/10/2021 16:22
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908331
Page 139 of 672
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908332
Page 140 of 672
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908333
Page 141 of 672
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908334
Page 142 of 672
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908335
Page 143 of 672
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908336
Page 144 of 672
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908337
Page 145 of 672
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908338
Page 146 of 672
***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: 10421217 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 Oct/27/2020
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908339
Page 147 of 672
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 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
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908340
Page 148 of 672
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4)
FDA-CBER-2021-5683-0908341
Page 149 of 672
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-11-2020 11:30:47 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908342
Page 150 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-29-2020 16:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908343
Page 151 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-29-2020 16:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908344
Page 152 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-29-2020 16:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908345
Page 153 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-29-2020 16:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908346
Page 154 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-29-2020 16:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908347
Page 155 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-29-2020 16:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908348
Page 156 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Oct-29-2020 16:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908349
Page 157 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Oct-29-2020 16:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908350
Page 158 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Oct-29-2020 16:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908351
Page 159 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Oct-29-2020 16:23:09 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908352
Page 160 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-29-2020 16:25:01 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908353
Page 161 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-29-2020 16:25:01 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908354
Page 162 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-29-2020 16:25:01 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908355
Page 163 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-29-2020 16:25:01 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908356
Page 164 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-29-2020 16:25:01 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908357
Page 165 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-29-2020 16:25:01 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908358
Page 166 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Oct-29-2020 16:25:01 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908359
Page 167 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-29-2020 16:25:47 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908360
Page 168 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-29-2020 16:25:47 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908361
Page 169 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-29-2020 16:25:47 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908362
Page 170 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-29-2020 16:25:47 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908363
Page 171 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-29-2020 16:25:47 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908364
Page 172 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908365
Page 173 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908366
Page 174 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908367
Page 175 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908368
Page 176 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908369
Page 177 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908370
Page 178 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908371
Page 179 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908372
Page 180 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908373
Page 181 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908374
Page 182 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908375
Page 183 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908376
Page 184 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908377
Page 185 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908378
Page 186 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908379
Page 187 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908380
Page 188 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908381
Page 189 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908382
Page 190 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908383
Page 191 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908384
Page 192 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908385
Page 193 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908386
Page 194 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908387
Page 195 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908388
Page 196 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908389
Page 197 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908390
Page 198 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908391
Page 199 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908392
Page 200 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908393
Page 201 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908394
Page 202 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908395
Page 203 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908396
Page 204 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-29-2020 16:25:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908397
Page 205 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908398
Page 206 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908399
Page 207 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908400
Page 208 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908401
Page 209 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908402
Page 210 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908403
Page 211 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908404
Page 212 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908405
Page 213 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908406
Page 214 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908407
Page 215 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908408
Page 216 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908409
Page 217 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908410
Page 218 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908411
Page 219 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908412
Page 220 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908413
Page 221 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908414
Page 222 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908415
Page 223 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908416
Page 224 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908417
Page 225 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908418
Page 226 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908419
Page 227 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908420
Page 228 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908421
Page 229 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908422
Page 230 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908423
Page 231 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908424
Page 232 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908425
Page 233 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 fOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908426
Page 234 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908427
Page 235 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908428
Page 236 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908429
Page 237 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908430
Page 238 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908431
Page 239 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908432
Page 240 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908433
Page 241 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5 hOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908434
Page 242 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908435
Page 243 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908436
Page 244 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908437
Page 245 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908438
Page 246 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908439
Page 247 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908440
Page 248 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908441
Page 249 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jOct-29-2020 16:26:13 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908442
Page 250 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-29-2020 16:26:44 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908443
Page 251 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-29-2020 16:26:44 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908444
Page 252 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aOct-29-2020 16:26:44 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908445
Page 253 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aOct-29-2020 16:26:44 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908446
Page 254 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aOct-29-2020 16:26:44 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908447
Page 255 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aOct-29-2020 16:26:44 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908448
Page 256 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-29-2020 16:27:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908449
Page 257 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-29-2020 16:27:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908450
Page 258 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aOct-29-2020 16:27:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908451
Page 259 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-29-2020 16:27:47 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908452
Page 260 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-29-2020 16:27:47 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908453
Page 261 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-29-2020 16:27:47 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908454
Page 262 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-29-2020 16:27:47 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908455
Page 263 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-29-2020 16:27:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908456
Page 264 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-29-2020 16:27:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908457
Page 265 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-29-2020 16:27:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908458
Page 266 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-29-2020 16:27:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908459
Page 267 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-29-2020 16:27:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908460
Page 268 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-29-2020 16:27:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908461
Page 269 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Oct-29-2020 16:27:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908462
Page 270 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-29-2020 16:28:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908463
Page 271 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-29-2020 16:28:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908464
Page 272 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-29-2020 16:28:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908465
Page 273 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-29-2020 16:28:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908466
Page 274 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Oct/27/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-29-2020 16:28:12 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0908467
Page 275 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: DATE OF VISIT - ILLNESS ONSET - 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Dec-29-2020 15:00:57 (UTC-06:00) Central Time
(US & Canada)Not applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908468
Page 276 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: DATE OF VISIT - ILLNESS ONSET - 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-06-2021 15:24:54 (UTC-06:00) Central Time
(US & Canada)
2Dec-30-2020 10:44:22 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908469
Page 277 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormDec-15-2020 08:21:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908470
Page 278 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Dec-15-2020 08:21:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908471
Page 279 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Dec-15-2020 08:21:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908472
Page 280 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Dec-15-2020 08:21:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908473
Page 281 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.aDec-15-2020 08:21:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908474
Page 282 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.bDec-15-2020 08:21:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908475
Page 283 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.cDec-15-2020 08:21:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908476
Page 284 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.dDec-15-2020 08:21:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908477
Page 285 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.eDec-15-2020 08:21:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908478
Page 286 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4 fDec-15-2020 08:21:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908479
Page 287 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.gDec-15-2020 08:21:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908480
Page 288 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4 hDec-15-2020 08:21:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908481
Page 289 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthFirst Medical Group
Subject No: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4.iDec-15-2020 08:21:59 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908482
Page 290 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-12-2021 07:36:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908483
Page 291 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-12-2021 07:36:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
1Dec-15-2020 08:28:46 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908484
Page 292 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-12-2021 07:36:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
2Dec-15-2020 08:28:56 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908485
Page 293 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-12-2021 07:36:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
3Dec-15-2020 08:29:10 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908486
Page 294 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-12-2021 07:36:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908487
Page 295 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: 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: 10421217 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Jan-12-2021 07:36:35 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e43\Final\Final On: 01-Apr-2021 04:50 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0908488
Page 296 of 672
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit on
Nov/30/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1042 Site Name: (1042) HealthF
…[truncated]