125742 S1 M5 CRF c4591001 1171 11711212

Document text

Page 1 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945003
Page 2 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/9/2020
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945004
Page 3 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11711212]
2.Birth Date: /1987
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): ASIAN
6.Racial Designation:
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945005
Page 4 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945006
Page 5 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945007
Page 6 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/9/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945008
Page 7 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945009
Page 8 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
2.Weight: [162.8]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [25.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945010
Page 9 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/9/2020
2.Randomization Number: [85864]
3.Randomization Group: [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945011
Page 10 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BP9HFM]
5.bSample ID [BP9HFN]
5.cSample ID [BP9HFP]
5.dSample ID [BRTT2G]
5.eSample ID [BRTT2H]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945012
Page 11 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BP0ZCR]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945013
Page 12 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/9/2020 16:07
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945014
Page 13 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945015
Page 14 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945016
Page 15 of 294
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Oct/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [96.3]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945017
Page 16 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9PXK]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945018
Page 17 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/16/2020 15:11
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945019
Page 18 of 294
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/18/2020
2.Erroneous Visit
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945020
Page 19 of 294
***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, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/18/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR0C5J]
5.bSample ID [BR0C5K]
5.cSample ID [BR0C5L]
5.dSample ID [BPHHZF]
5.eSample ID [BPHHZG]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945021
Page 20 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/7/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945022
Page 21 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/7/2020
2.Date of First Symptom Started: Dec/4/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/30/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? 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
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945023
Page 22 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Symptoms - Other
5.aSymptoms - Other Text: [Body Aches]
5.bSymptoms - Other Text: [Headache]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945024
Page 23 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Dec/12/20
20 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945025
Page 24 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/12/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: OTHER Comments
7.Test Result: POSITIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [Quidel Sofia 2 SARS Antigen FIA] Comments
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945026
Page 25 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Dec/7/2020
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 [CV07097]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945027
Page 26 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Subject collected a self swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945028
Page 27 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: 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?YES
Has the subject been in intensive care due to potential COVID-19 illness?
YES
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945029
Page 28 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Dec/12/2020  NO
Discharge Date:
Dec/18/2020
 Repeating Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945030
Page 29 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Dec/12/2020
4.Ongoing? NO
Discharge Date:
Dec/18/2020
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945031
Page 30 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945032
Page 31 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945033
Page 32 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Covid-19 Pneumonia]
Date of Diagnosis:
Dec/13/2020
3.Toxicity Grade: 2
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945034
Page 33 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945035
Page 34 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945036
Page 35 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945037
Page 36 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945038
Page 37 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945039
Page 38 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945040
Page 39 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945041
Page 40 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945042
Page 41 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945043
Page 42 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945044
Page 43 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945045
Page 44 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945046
Page 45 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945047
Page 46 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945048
Page 47 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945049
Page 48 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945050
Page 49 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/08/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945051
Page 50 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loca
tionAssay Code and Descrip
tionDevice Ty
peForm Instance
 1.          Repeating
Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945052
Page 51 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/08/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Microbiology Specimen
1.Actual Date of Collection: //
2.Specimen Type:
3.Specimen Collection Location:
4.Assay Code and Description:
5.Device Type:
6.Trade Name:
7.Test Result:
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945053
Page 52 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945054
Page 53 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/08/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945055
Page 54 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945056
Page 55 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/08/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945057
Page 56 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
 1.       Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945058
Page 57 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945059
Page 58 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945060
Page 59 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/08/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945061
Page 60 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945062
Page 61 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/08/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945063
Page 62 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945064
Page 63 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/08/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945065
Page 64 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945066
Page 65 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/08/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945067
Page 66 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945068
Page 67 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/08/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945069
Page 68 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945070
Page 69 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/08/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945071
Page 70 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/08/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945072
Page 71 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Jan/08/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/8/2021
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 [BP9PBX]
5.bSample ID [BP9PBY]
5.cSample ID [BP9PBZ]
5.dSample ID [BP9PC0]
5.eSample ID [BP9PC1]
5.fSample ID [BLG552]
5.gSample ID [BLG553]
5 hSample ID [BLG554]
5.iSample ID [BLG555]
5.jSample ID [BLG557]
5 kSample ID [BLG559]
5.lSample ID [BLG558]
5.mSample ID [BLG556]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945073
Page 72 of 294
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/23/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/23/2020
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945074
Page 73 of 294
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/23/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Unplanned Assessments
1.Assessments Not Done Comments
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945075
Page 74 of 294
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/23/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Contact Outcome
1.Contact Type: Not Done Comments
2.Was contact made? Not Done Comments
3.Comments: Not Done
[ ]Comments
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945076
Page 75 of 294
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/23/2020Form: VITAL SIGNS - TEMP
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Temperature: Not Applicable
[ ]Comments
Unit: Not Applicable Comments
Temperature Location: Not Applicable Comments
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945077
Page 76 of 294
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/23/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Unplanned Assessment Of Local Reaction
1.Date of Assessment: Not Applicable
//Comments
2.Injection Site Location Not Applicable Comments
3.Injection Site Body Side: Not Applicable Comments
Reaction
4.aReaction: REDNESS
Reaction Present: Not Applicable Comments
4.bReaction: SWELLING
Reaction Present: Not Applicable Comments
Symptom
5.aSymptom: PAIN AT INJECTION SITE
Symptom Present: Not Applicable Comments
5.bSymptom: FATIGUE/TIREDNESS
Symptom Present: Not Applicable Comments
5.cSymptom: HEADACHE
Symptom Present: Not Applicable Comments
5.dSymptom: VOMITING
Symptom Present: Not Applicable Comments
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945078
Page 77 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/23/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.eSymptom: DIARRHEA
Symptom Present: Not Applicable Comments
5.fSymptom: NEW OR WORSENED MUSCLE PAIN
Symptom Present: Not Applicable Comments
5.gSymptom: NEW OR WORSENED JOINT PAIN
Symptom Present: Not Applicable Comments
5.hSymptom: CHILLS
Symptom Present: Not Applicable Comments
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945079
Page 78 of 294
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/18/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945080
Page 79 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945081
Page 80 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945082
Page 81 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945083
Page 82 of 294
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1. DELETED ADVERSE E
VENT 1  SARS-CoV-2 Il
lness Dec/4/2020 1
7:00 NO
End Date Time:
Dec/30/2020 15:00
 Repeating
Pages
 2. DELETED ADVERSE E
VENT 2  Covid-19 Pneu
monia Dec/13/2020
00:00 NO
End Date Time:
Dec/30/2020 00:00
 Repeating
Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945084
Page 83 of 294
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[SARS CoV2 Illness ]
4.Start Date Time: Dec/4/2020 17:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/30/2020 15:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
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:
[SARS CoV2 Illness ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945085
Page 84 of 294
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945086
Page 85 of 294
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Covid-19 Pneumonia ]
4.Start Date Time: Dec/13/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/30/2020 00:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945087
Page 86 of 294
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[SARS-CoV-2 Illness ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020511149 ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945088
Page 87 of 294
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945089
Page 88 of 294
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945090
Page 89 of 294
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945091
Page 90 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945092
Page 91 of 294
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945093
Page 92 of 294
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945094
Page 93 of 294
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945095
Page 94 of 294
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945096
Page 95 of 294
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945097
Page 96 of 294
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945098
Page 97 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945099
Page 98 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945100
Page 99 of 294
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945101
Page 100 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945102
Page 101 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945103
Page 102 of 294
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945104
Page 103 of 294
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945105
Page 104 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945106
Page 105 of 294
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945107
Page 106 of 294
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945108
Page 107 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945109
Page 108 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Mar/8/2021
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945110
Page 109 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945111
Page 110 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Mar/8/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945112
Page 111 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/8/2021
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 [BR2ZL1]
5.bSample ID [BS8376]
5.cSample ID [BS8377]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945113
Page 112 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/8/2021
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 [BR2ZKF]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945114
Page 113 of 294
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/8/2021 09:34
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
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
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945115
Page 114 of 294
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945116
Page 115 of 294
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945117
Page 116 of 294
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945118
Page 117 of 294
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945119
Page 118 of 294
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945120
Page 119 of 294
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945121
Page 120 of 294
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945122
Page 121 of 294
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945123
Page 122 of 294
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945124
Page 123 of 294
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945125
Page 124 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/18/2020
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945126
Page 125 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945127
Page 126 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945128
Page 127 of 294
***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: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-09-2020 16:49:56 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945129
Page 128 of 294
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormSep-09-2020 16:54:10 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945130
Page 129 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormMar-08-2021 17:03:15 (UTC-06:00) Central
Time (US & Canada)
FormDec-14-2020 08:26:39 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945131
Page 130 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Mar-08-2021 17:03:15 (UTC-06:00) Central
Time (US & Canada)
1Dec-14-2020 08:26:39 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945132
Page 131 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Mar-08-2021 17:03:15 (UTC-06:00) Central
Time (US & Canada)
2Dec-14-2020 08:26:39 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945133
Page 132 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Mar-08-2021 17:03:15 (UTC-06:00) Central
Time (US & Canada)
3Dec-14-2020 08:26:39 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945134
Page 133 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Mar-08-2021 17:03:15 (UTC-06:00) Central
Time (US & Canada)
4Dec-14-2020 08:26:39 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945135
Page 134 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Mar-08-2021 17:03:15 (UTC-06:00) Central
Time (US & Canada)
5Dec-14-2020 08:26:39 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945136
Page 135 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Mar-08-2021 17:03:15 (UTC-06:00) Central
Time (US & Canada)
6Dec-14-2020 08:26:39 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945137
Page 136 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
7Mar-08-2021 17:03:15 (UTC-06:00) Central
Time (US & Canada)
7Dec-14-2020 08:26:39 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945138
Page 137 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
8Mar-08-2021 17:03:15 (UTC-06:00) Central
Time (US & Canada)
8Dec-14-2020 08:26:39 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945139
Page 138 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
9Mar-08-2021 17:03:15 (UTC-06:00) Central
Time (US & Canada)
9Dec-14-2020 08:26:39 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945140
Page 139 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-14-2020 08:25:09 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945141
Page 140 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Dec-14-2020 08:25:09 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945142
Page 141 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Dec-14-2020 08:25:09 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945143
Page 142 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Dec-14-2020 08:25:09 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945144
Page 143 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4Dec-14-2020 08:25:09 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945145
Page 144 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5Dec-14-2020 08:25:09 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945146
Page 145 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
6Dec-14-2020 08:25:09 (UTC-06:00) Central
Time (US & Canada)Mueed Bari Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945147
Page 146 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/23/2020Form: UNPLANNED VISIT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormMar-01-2021 12:09:45 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945148
Page 147 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED VISIT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Mar-01-2021 12:09:45 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945149
Page 148 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/23/2020Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormMar-01-2021 12:10:29 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945150
Page 149 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Mar-01-2021 12:10:29 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945151
Page 150 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Mar-01-2021 12:10:29 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945152
Page 151 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Mar-01-2021 12:10:29 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945153
Page 152 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/23/2020Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-04-2021 17:09:49 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945154
Page 153 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Jan-04-2021 17:09:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945155
Page 154 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aJan-04-2021 17:09:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945156
Page 155 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aJan-04-2021 17:09:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945157
Page 156 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aJan-04-2021 17:09:49 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945158
Page 157 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Dec/23/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-04-2021 17:10:57 (UTC-06:00) Central
Time (US & Canada)Subject tested positive for SARS-CoV-2 Illness,
we are awaiting medical records
Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945159
Page 158 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Jan-04-2021 17:10:57 (UTC-06:00) Central Time
(US & Canada)Subject tested positive for SARS-CoV-2 Illness,
we are awaiting medical records
Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945160
Page 159 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Jan-04-2021 17:10:57 (UTC-06:00) Central Time
(US & Canada)Subject tested positive for SARS-CoV-2 Illness,
we are awaiting medical records
Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945161
Page 160 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Jan-04-2021 17:10:57 (UTC-06:00) Central Time
(US & Canada)Subject tested positive for SARS-CoV-2 Illness,
we are awaiting medical records
Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945162
Page 161 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4.aJan-04-2021 17:10:57 (UTC-06:00) Central Time
(US & Canada)Subject tested positive for SARS-CoV-2 Illness,
we are awaiting medical records
Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945163
Page 162 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
4.bJan-04-2021 17:10:57 (UTC-06:00) Central Time
(US & Canada)Subject tested positive for SARS-CoV-2 Illness,
we are awaiting medical records
Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945164
Page 163 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.aJan-04-2021 17:10:57 (UTC-06:00) Central Time
(US & Canada)Subject tested positive for SARS-CoV-2 Illness,
we are awaiting medical records
Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945165
Page 164 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.bJan-04-2021 17:10:57 (UTC-06:00) Central Time
(US & Canada)Subject tested positive for SARS-CoV-2 Illness,
we are awaiting medical records
Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945166
Page 165 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.cJan-04-2021 17:10:57 (UTC-06:00) Central Time
(US & Canada)Subject tested positive for SARS-CoV-2 Illness,
we are awaiting medical records
Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945167
Page 166 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.dJan-04-2021 17:10:57 (UTC-06:00) Central Time
(US & Canada)Subject tested positive for SARS-CoV-2 Illness,
we are awaiting medical records
Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945168
Page 167 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.eJan-04-2021 17:10:57 (UTC-06:00) Central Time
(US & Canada)Subject tested positive for SARS-CoV-2 Illness,
we are awaiting medical records
Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945169
Page 168 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 fJan-04-2021 17:10:57 (UTC-06:00) Central Time
(US & Canada)Subject tested positive for SARS-CoV-2 Illness,
we are awaiting medical records
Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945170
Page 169 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5.gJan-04-2021 17:10:57 (UTC-06:00) Central Time
(US & Canada)Subject tested positive for SARS-CoV-2 Illness,
we are awaiting medical records
Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945171
Page 170 of 294
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 10-Dec-2020 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
5 hJan-04-2021 17:10:57 (UTC-06:00) Central Time
(US & Canada)Subject tested positive for SARS-CoV-2 Illness,
we are awaiting medical records
Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945172
Page 171 of 294
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormMar-08-2021 10:40:19 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0945173
Page 172 of 294
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Mar-08-2021 17:03:15 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Earl Martin  Approved Mar-08-2021 11:13:29 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EarlMartin, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-08-2021 10:39:08 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Earl Martin  Approved Mar-07-2021 18:13:32 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EarlMartin, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945174
Page 173 of 294
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
 N/A Feb-04-2021 13:54:59 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Earl Martin  Approved Jan-28-2021 12:27:38 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EarlMartin, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-08-2021 15:59:45 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Earl Martin  Approved Jan-07-2021 10:20:34 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EarlMartin, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-06-2021 07:52:49 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Earl Martin  Approved Jan-05-2021 17:36:10 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945175
Page 174 of 294
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
By my dated signature below, I, EarlMartin, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-23-2020 17:02:51 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Earl Martin  Approved Dec-15-2020 10:17:55 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EarlMartin, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Mueed Bari  N/A Dec-14-2020 08:21:15 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Earl Martin  Approved Dec-09-2020 13:34:16 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EarlMartin, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945176
Page 175 of 294
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Mueed Bari  N/A Nov-18-2020 16:27:41 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Earl Martin  Approved Nov-09-2020 08:31:38 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EarlMartin, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945177
Page 176 of 294
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-09-2020 16:48:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-09-2020 16:48:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0945178
Page 177 of 294
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-09-2020 16:48:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/9/2020Initial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0945179
Page 178 of 294
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-09-2020 16:48:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11711212Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-09-2020 16:48:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1987Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-09-2020 16:49:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-10-2020 08:04:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-09-2020 16:49:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ASIANInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0945180
Page 179 of 294
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-18-2020 04:42:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-16-2020 15:43:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Query 1: Answered Subject V2
conducted and
completed.
Oct-06-2020 05:00:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM1: Thank you
for the response.
Please keep this
query open at your
end. Once visit is
performed, kindly
update vaccination
details and rest of
the visit pages and
then respond to the
query
Oct-05-2020 09:43:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject V2VX2L
scheduled for
7/Oct/2020. Thank
you.
Oct-05-2020 09:19:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Details on visit
‘V2VX2L’ are
missing. Kindly
consider to update
or else clarify.
Thank you.
Sep-09-2020 16:49:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0945181
Page 180 of 294
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-09-2020 16:53:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-09-2020 16:53:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-09-2020 16:53:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0945182
Page 181 of 294
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020 08:05:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-10-2020 08:05:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
162.8Initial Entry
3. Unit:
Date Location User Value Reason
Sep-10-2020 08:05:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-10-2020 08:05:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
67.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-10-2020 08:05:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-10-2020 08:05:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25.5Initial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0945183
Page 182 of 294
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7.a
Date Location User Value Reason
Sep-10-2020 08:05:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.7
Temperature Unit: F
Temperature Locatio
n::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-10-2020 08:05:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-10-2020 08:05:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-10-2020 08:05:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-10-2020 08:05:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0945184
Page 183 of 294
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-10-2020 08:05:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-10-2020 08:05:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
85864Initial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0945185
Page 184 of 294
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 08:05:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 08:05:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 08:06:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-10-2020 08:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-10-2020 08:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020 08:06:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9HFMInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0945186
Page 185 of 294
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Sep-10-2020 08:06:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP9HFMInitial Entry
5.b
Date Location User Value Reason
Sep-10-2020 08:06:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9HFNInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-10-2020 08:06:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP9HFNInitial Entry
5.c
Date Location User Value Reason
Sep-10-2020 08:06:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9HFPInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-10-2020 08:06:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP9HFPInitial Entry
5.d
Date Location User Value Reason
Sep-10-2020 08:06:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTT2GInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0945187
Page 186 of 294
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.d Sample ID
Date Location User Value Reason
Sep-10-2020 08:06:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BRTT2GInitial Entry
5.e
Date Location User Value Reason
Sep-10-2020 08:06:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTT2HInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-10-2020 08:06:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BRTT2HInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0945188
Page 187 of 294
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 08:06:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 08:06:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 08:06:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-10-2020 08:06:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-10-2020 08:06:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020 08:06:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP0ZCRInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0945189
Page 188 of 294
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Sep-10-2020 08:06:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP0ZCRInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0945190
Page 189 of 294
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-10-2020 08:05:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020 08:05:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020 08:05:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-10-2020 08:05:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020 16:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020 08:05:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-10-2020 08:05:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0945191
Page 190 of 294
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7. Route:
Date Location User Value Reason
Sep-10-2020 08:05:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-10-2020 08:05:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-10-2020 08:05:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0945192
Page 191 of 294
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-10-2020 08:05:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0945193
Page 192 of 294
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020
01:28:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clos
edAs per site
confirmation -
updated PD tracker
Oct-19-2020
08:27:21
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Mueed Bari Query
1: Ans
weredSubject out of
window due to
scheduling conflicts.
Subject reeducated
on study visit
window compliance,
and verbalized
understanding.
Oct-19-2020
01:06:27
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Ope
nedPDQ: Date of visit at
V2_VAX2_L is out
of window for 14
days from
V1_DAY1_VAX1_L
Dose Date. Please
verify and update.
Else, confirm in
query response
appropriately. "[
]"
Oct-16-2020
15:31:11
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Mueed Bari Data E
ntry:
Oct/16/
2020Initial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945194
Page 193 of 294
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Oct-16-2020 15:31:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Oct/16/2020Initial Entry
2.a
Date Location User Value Reason
Oct-16-2020 15:31:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Record Identifier:: 1
Temperature: 96.3
Temperature Unit: F
Temperature Locati
on::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-16-2020 15:31:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-17-2020 07:50:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Saumitra
DubeyQuery 1: Closed Response satisfies
query
Oct-16-2020 15:33:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Query 1: Answered Per Sub-I, NCS.
Oct-16-2020 15:31:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature 96.3 F
is outside of Normal
Range 97 - 99.5 F.
Oct-16-2020 15:31:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
96.3Initial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945195
Page 194 of 294
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.a Unit:
Date Location User Value Reason
Oct-16-2020 15:31:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-16-2020 15:31:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
FOREHEADInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945196
Page 195 of 294
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 15:31:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 15:31:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 15:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-16-2020 15:31:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-16-2020 15:31:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
Oct-16-2020 15:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BP9PXKInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945197
Page 196 of 294
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 15:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BP9PXKInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945198
Page 197 of 294
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-16-2020 15:32:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-16-2020 15:32:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-16-2020 15:32:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-16-2020 15:32:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Oct/16/2020 15:11Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-16-2020 15:32:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-16-2020 15:32:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
LEFTInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945199
Page 198 of 294
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7. Route:
Date Location User Value Reason
Oct-16-2020 15:32:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-16-2020 15:32:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-16-2020 15:43:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
YESInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945200
Page 199 of 294
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-18-2020 16:27:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Nov/18/2020Initial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945201
Page 200 of 294
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-18-2020 16:27:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-18-2020 16:27:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-18-2020 16:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-18-2020 16:27:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-18-2020 16:27:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
YES
Date of Collection:
Nov/18/2020Initial Entry
5.a
Date Location User Value Reason
Nov-18-2020 16:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BR0C5JInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945202
Page 201 of 294
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Nov-18-2020 16:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BR0C5JInitial Entry
5.b
Date Location User Value Reason
Nov-18-2020 16:28:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BR0C5KInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-18-2020 16:28:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BR0C5KInitial Entry
5.c
Date Location User Value Reason
Nov-18-2020 16:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BR0C5LInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-18-2020 16:28:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BR0C5LInitial Entry
5.d
Date Location User Value Reason
Nov-18-2020 16:28:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BPHHZFInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945203
Page 202 of 294
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.d Sample ID
Date Location User Value Reason
Nov-18-2020 16:28:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BPHHZFInitial Entry
5.e
Date Location User Value Reason
Nov-18-2020 16:28:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: BPHHZGInitial Entry
5.e Sample ID
Date Location User Value Reason
Nov-18-2020 16:28:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
BPHHZGInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945204
Page 203 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-08-2021 13:16:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 3: Closed Response satisfies
query
Feb-08-2021 00:22:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed Response satisfies
query
Feb-05-2021 13:14:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Not Applicable
Feb-05-2021 13:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered Changed data per
query
Jan-21-2021 07:01:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened DM: Kindly review
and complete
‘Hospitalization
Details form' at this
visit. Thank you.
Jan-19-2021 12:29:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 3: Opened Clin: It was stated in
the SAE report
#2020511149 that
the subject was
hospitalized. Please
obtain subject
medical records and
update as appropriate
CRF forms (COVID
TEST, ILL
SEVERE, LAB
CHEM/HME,
VITALA, PULSE
OX, OXYGEN,
VASOPRESS,
IMAGING)
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945205
Page 204 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Dec-14-2020 08:21:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-14-2020 08:21:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in the
Signs and Symptoms
form is missing.
Please review and
update as
appropriate.
Dec-14-2020 08:21:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in both
Nasal Swab Self and
Nasal Swab are
missing. Please
review and update as
appropriate.
Dec-14-2020 08:21:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Dec/7/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-14-2020 08:21:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945206
Page 205 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Dec/7/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-22-2021 11:28:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
Jan-18-2021 14:21:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Jan-02-2021 14:16:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Reissued:Opened Clin: Query open
until this CRF form
is updated
Dec-30-2020 13:01:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered We are currently
waiting for their
medical records
Dec-24-2020 09:20:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: It was stated in
the SAE report
#2020511149 that
the subject
experienced a
SARS-COV-2
illness, please
confirm that all the
information are
correctly entered in
the corresponding
potential COVID-19
visit CRF forms
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Dec/4/2020Initial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945207
Page 206 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-14-2021 23:42:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 2: Closed Response satisfies
query
Feb-10-2021 11:01:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Changed
Information
Feb-10-2021 11:01:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolve
d:
Dec/30/2020Changed
Information
Feb-08-2021 15:25:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 2: Opened Clin: There is a
discrepancy between
the COVID-19
PNEUMONIA end
date 30Dec2020 on
the AE CRF page
and date of the last
symptom
18Dec2020 on the
CRF SIGNS AND
SYMPTOMS OF
POTENTIAL
COVID-19 form.
Please review and
update as
appropriate
Jan-22-2021 11:28:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
Jan-20-2021 16:20:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Jan-20-2021 16:20:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolve
d:Changed
Information
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945208
Page 207 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Dec/18/2020
Jan-19-2021 12:32:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: It was stated in
the SAE report
#2020511149 that
"Per subject, all
symptoms were
resolved for the
subject by the time
he was discharged
ON 18Dec2020".
Please review and
update as
appropriate the Date
of Last Symptom
Resolved.
Jan-18-2021 14:21:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resolve
d:
Dec/30/2020New Information
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
FEVERInitial Entry
4.a Was symptom present?
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945209
Page 208 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Symptoms: NEW OR INCREAS
ED COUGH
Symptom P
resent:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945210
Page 209 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.c Symptoms:
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NEW OR INCREASED SHORTN
ESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Symptoms
:NEW OR INCREASE
D MUSCLE PAINInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945211
Page 210 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Symptom
Present:NO
4.e Symptoms:
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NEW OR INCREASED MUSCLE
PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Symptoms
:NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
4.g
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945212
Page 211 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Symptom
s:NEW OR INCREASE
D SORE THROAT
Symptom
Present:YESInitial Entry
4.g Symptoms:
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NEW OR INCREASED SORE TH
ROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945213
Page 212 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.i
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Dec-14-2020 08:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Dec-14-2020 08:23:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Symptoms - Other: Body AchesInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Dec-14-2020 08:23:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Body AchesInitial Entry
5.b
Date Location User Value Reason
Dec-14-2020 08:23:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Symptoms - Other: HeadacheInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945214
Page 213 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.b Symptoms - Other Text:
Date Location User Value Reason
Dec-14-2020 08:23:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
HeadacheInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945215
Page 214 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Mar-08-2021 17:06:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945216
Page 215 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Mar-10-2021 07:23:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
Mar-08-2021 17:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Mar-08-2021 17:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/12/2020Initial Entry
Mar-08-2021 17:03:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Jan-02-2021 14:15:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Reissued:Opened Clin: Query open
until this CRF form is
updated
Dec-30-2020 13:01:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered We are currently
waiting for their
medical records
Dec-28-2020 10:44:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: It was stated in
the SAE report
#2020511149 that the
subject had a
SARS-CoV-2 NAAT
test result positive on
12Dec2020. Please
update the
MICROBIOLOGY
SPECIMEN
Dec-14-2020 08:26:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Not ApplicableInitial Entry
2. Specimen Type:
Date Location User Value Reason
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945217
Page 216 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Mar-08-2021 17:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
Mar-08-2021 17:03:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Dec-14-2020 08:26:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Not ApplicableInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Mar-08-2021 17:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
Mar-08-2021 17:03:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Dec-14-2020 08:26:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Not ApplicableInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Mar-08-2021 17:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2Initial Entry
Mar-08-2021 17:03:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Dec-14-2020 08:26:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Not ApplicableInitial Entry
5. Device Type:
Date Location User Value Reason
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945218
Page 217 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Mar-08-2021 17:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TE
STInitial Entry
Mar-08-2021 17:03:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Dec-14-2020 08:26:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Not ApplicableInitial Entry
6. Trade Name:
Date Location User Value Reason
Mar-08-2021 17:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
Mar-08-2021 17:03:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Dec-14-2020 08:26:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Not ApplicableInitial Entry
7. Test Result:
Date Location User Value Reason
Mar-08-2021 17:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
POSITIVEInitial Entry
Mar-08-2021 17:03:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Dec-14-2020 08:26:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Not ApplicableInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945219
Page 218 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Mar-08-2021 17:03:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Dec-14-2020 08:26:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Not ApplicableInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Mar-08-2021 17:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Quidel Sofia 2 SARS Antigen FI
AInitial Entry
Mar-08-2021 17:03:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Dec-14-2020 08:26:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Not ApplicableInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945220
Page 219 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-14-2020 08:21:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-14-2020 08:21:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-10-2021 14:33:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 2: Closed Response satisfies
query
Jan-08-2021 17:14:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Email was received
stating laboratory
has received the
sample
Jan-05-2021 11:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 2: Opened Clin: The central lab
did not receive the
nasal swab
collected. Please
could you confirm
that the sample was
sent to the central
lab and that the
barcode is accurate.
Dec-14-2020 08:21:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-14-2020 08:21:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945221
Page 220 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
entered. Please
review and correct
as appropriate.
Dec-14-2020 08:21:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
YES
Date of Collection:
Dec/7/2020Initial Entry
5.a
Date Location User Value Reason
Dec-14-2020 08:21:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Sample ID: CV07097Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-14-2020 08:21:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
CV07097Initial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945222
Page 221 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-14-2020 08:22:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-14-2020 08:22:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-14-2020 08:22:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Dec-14-2020 08:22:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Subject collected a self swabInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945223
Page 222 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits o
r Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Jan-20-2021 16:28:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practit
ioner:EMERGENCY
ROOM
Occurrence of
Visits or Conta
cts:YES
Number of Vis
its or Contact
s:
1New Information
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Type of Practition
er:EMERGEN
CY ROOMInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945224
Page 223 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Occurrence of Vis
its or Contacts:NO
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Jan-22-2021 11:29:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
Jan-20-2021 16:28:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Jan-20-2021 16:28:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1New Information
Jan-19-2021 12:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: It was stated in
the SAE report
#2020511149 that
the subject
experienced
SARS-CoV-2 illness
on 04Dec2020,
which required a
visit to emergency
room Please review
and update as
appropriate this CRF
form.
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945225
Page 224 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.c
Date Location User Value Reason
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of V
isits or Contacts
:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Type of Practitioner: URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945226
Page 225 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Contac
ts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945227
Page 226 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari
)Data Entry:
Type of Practitioner: OTHE
R
Occurrence of Visits or C
ontacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Jan-22-2021 11:29:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
Jan-20-2021 16:27:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Jan-20-2021 16:27:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Has the subject been in intensiv
e care due to potential COVID-
19 illness?
YESNew Information
Jan-19-2021 12:14:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: It was stated in
the SAE report
#2020511149 that
the subject was
hospitalized from
12Dec to
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945228
Page 227 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
18Dec2020 for
SARS-COV-2
illness. Please
review and update as
appropriate CRF
forms. Please
confirm if the
subject was admitted
in ICU
Dec-14-2020 08:24:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945229
Page 228 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: HOSPITALIZATION DETAILS - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Feb-05-2021 13:08:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945230
Page 229 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Feb-05-2021 13:08:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Feb-14-2021 23:42:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
Feb-10-2021 15:36:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Feb-08-2021 15:05:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Reissued:Opened Clin: It was stated in
the SAE report
#2020511149 that
the subject was
hospitalized from
12Dec2020. Please
review and
update/confirm as
appropriate the CRF
form.
Feb-05-2021 13:08:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Feb-05-2021 13:08:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HOSPITALInitial Entry
Jan-22-2021 11:30:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: It was stated in
the SAE report
#2020511149 that
the subject was
hospitalized from
12Dec to 18Dec2020
for SARS-COV-2
illness. Please
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945231
Page 230 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
review and update as
appropriate the CRF
form. Please confirm
if the subject was
admitted in ICU
3. Admission Date:
Date Location User Value Reason
Feb-10-2021 15:36:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/12/2020Transcription Error
Feb-05-2021 13:08:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/13/2020Initial Entry
4. Ongoing?
Date Location User Value Reason
Feb-05-2021 13:08:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Discharge Date:
Dec/18/2020Initial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945232
Page 231 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: RESPIRATORY TREATMENT - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. What is the treatment Identifier?
Date Location User Value Reason
Dec-14-2020 08:25:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Not ApplicableInitial Entry
2. Concomitant Non-drug Treatment Pre-specified:
Date Location User Value Reason
Dec-14-2020 08:25:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Not ApplicableInitial Entry
3. Treatment:
Date Location User Value Reason
Dec-14-2020 08:25:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Not ApplicableInitial Entry
4. Treatment:
Date Location User Value Reason
Dec-14-2020 08:25:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Not ApplicableInitial Entry
5. Start Date:
Date Location User Value Reason
Dec-14-2020 08:25:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
Not ApplicableInitial Entry
6. Ongoing?
Date Location User Value Reason
Dec-14-2020 08:25:09
(UTC-06:00) CentralACV0PFEINFP6000  Mueed Bari Data Entry:
Not ApplicableInitial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945233
Page 232 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: RESPIRATORY TREATMENT - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945234
Page 233 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Dec-14-2020 08:24:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Feb-05-2021 12:01:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
Feb-04-2021 13:56:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Feb-04-2021 13:56:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness Diagnosis:
Covid-19 Pneumonia
Date of Diagnosis:
Dec/13/2020Changed Information
Feb-04-2021 13:56:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Yes is selected,
however, either the
diagnosis details or
date of diagnosis is
missing. Please
correct.
Feb-04-2021 13:56:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Feb-04-2021 13:56:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Respiratory Illness Diagnosis:
Covid-19 PneumoniaChanged Information
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945235
Page 234 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/07/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Jan-19-2021 12:22:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin: It was stated in
the SAE report
#2020511149 that
the subject
experienced
PNEUMONIA.
Please consider in
response to "Was a
diagnosis obtained
for Potential
COVID-19 Illness"
entering COVID-19
PNEUMONIA
Dec-14-2020 08:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Dec-14-2020 08:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Mueed Bari Data Entry:
2Initial Entry
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0945236
Page 235 of 294
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/08/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-22-2021 04:33:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Deleted Query is invalid or
does not apply
Jan-22-2021 04:33:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Deleted Query is invalid or
does not apply
Jan-22-2021 04:33:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted Query is invalid or
does not apply
Jan-20-2021 16:24:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please either untick
the erroneous visit
button if visit
occurred, or mark
any forms
containing data
within this visit as
Not Done/Not
Applicable at the
form level.
Jan-20-2021 16:24:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Jan-20-2021 16:24:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
090177e196ae3d4b\Final\Final On: 01-Apr-2021 04:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945237
Page 236 of 294
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Jan/08/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1171 Site Name: (1171) Martin Diagnostic Clinic
Subject No: 11711212 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Please
…[truncated]