Document text
Page 1 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904800
Page 2 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/27/2020
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904801
Page 3 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10381051]
2.Birth Date: /1951
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904802
Page 4 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904803
Page 5 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904804
Page 6 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904805
Page 7 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Pain Syndrome]
Start Date: UNK/UNK/1992
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diabetic Neuropathy]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Facet Arthroplasty, cervical]
Start Date: UNK/UNK/1996
Ongoing: NO
End Date:
UNK/UNK/1996
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: UNK/UNK/2002
Ongoing: YES
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904806
Page 8 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2010
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: UNK/UNK/2010
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Lumbar Radiculopathy]
Start Date: UNK/UNK/1996
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis,multiple sites]
Start Date: UNK/UNK/2014
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Severe Obesity]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904807
Page 9 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left Hand Trigger Finger]
Start Date: Feb/UNK/2020
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Hand Trigger Finger]
Start Date: Feb/UNK/2020
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type 2 Diabetes Mellitus]
Start Date: UNK/UNK/2001
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Knee Replacement]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904808
Page 10 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left Knee Replacemnent]
Start Date: Dec/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Lumbar Vertebral Fusion]
Start Date: UNK/UNK/1995
Ongoing: NO
End Date:
UNK/UNK/1995
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904809
Page 11 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/27/2020
2.Weight: [245.8]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [36.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904810
Page 12 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/27/2020
2.Randomization Number: [243871]
3.Randomization Group: [ ]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904811
Page 13 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN62TY]
5.bSample ID [BN62TZ]
5.cSample ID [BN62V0]
5.dSample ID [BLB4H4]
5.eSample ID [BLB4H5]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904812
Page 14 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/27/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN6327]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904813
Page 15 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/27/2020 16:49
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904814
Page 16 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904815
Page 17 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904816
Page 18 of 305
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904817
Page 19 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/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 [BN636P]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904818
Page 20 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/18/2020 14:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904819
Page 21 of 305
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904820
Page 22 of 305
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/20/2020
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 [BRV9JC]
5.bSample ID [BRV9JD]
5.cSample ID [BPVFV3]
5.dSample ID [BPVFV4]
5.eSample ID [BPVFV5]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904821
Page 23 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904822
Page 24 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Nov/9/2020
2.Date of First Symptom Started: Nov/7/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/25/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904823
Page 25 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [chest tightness]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904824
Page 26 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
1.Nov/10/2
020 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SY
NDROME CORONAVIRUS
2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904825
Page 27 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/10/2020 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: [Hologic Aptima SARS-CoV-2 assay] Comments
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904826
Page 28 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Nov/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 [CV24085]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904827
Page 29 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[Self swab collected on Nov 09, 2020]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904828
Page 30 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904829
Page 31 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904830
Page 32 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Hospitalization CategoryHospitalization Ter
mAdmission Dat
eOngoing Form Instance
1.HOSPITALIZATION STATUS
ICU Nov/17/2020 NO
Discharge Date
:
Nov/22/2020
Repeating Pages
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904831
Page 33 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: ICU
3.Admission Date: Nov/17/2020
4.Ongoing? NO
Discharge Date:
Nov/22/2020
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904832
Page 34 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Iden
tifierCon Non-Drug Treatments Pre
-specifiedTreatment Treatment Start DateForm Instanc
e
1.Not Applicable Not Applicable Not Applica
ble Not Applica
ble Not Applica
ble Repeating
Pages
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904833
Page 35 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904834
Page 36 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19]
Date of Diagnosis:
Nov/10/2020
3.Toxicity Grade: 1
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904835
Page 37 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
1. Repeating
Pages
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904836
Page 38 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904837
Page 39 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category f
or Lab Tes
tVendor NameCollect
ion Da
te:Speci
men T
ypeLab ResultForm Insta
nce
1.CLINICA
L CHEMI
STRY Bristol Regional Medical Ce
nter, 1 Medical PArk Blv, Br
istol TN 37620 Nov/18
/2020 BLOO
D Sponsor-D
efined Ide
ntifierTest:Res
ult:
329 C Reactive Pr
otein_PX329 [ ]
30 Alanine Amin
otransferase_
PX30 14
28 Aspartate Am
inotransferase
_PX28 21
35 Alkaline Phos
phatase_PX3
5 56
21 Bilirubin_PX
21 0.4
47 Blood Urea N
itrogen_PX47
21
48 Creatinine_P
X48 0.8
5 Repeating
Pages
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904838
Page 40 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [Bristol Regional Medical Center, 1 Medical PArk Blv, Bristol TN 37620]
3.Collection Date: Nov/18/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [14]
Not Done:
LNMT Low
[0]
High
[40]
Unit
U/L
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904839
Page 41 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [21]
Not Done:
LNMT Low
[0]
High
[39]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [56]
Not Done:
LNMT Low
[39]
High
[117]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.4]
Not Done:
LNMT Low
[0.3]
High
[1.2]
Unit
mg/dL
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904840
Page 42 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [21]
Not Done:
LNMT Low
[6]
High
[23]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.85]
Not Done:
LNMT Low
[0.5]
High
[1.35]
Unit
mg/dL
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904841
Page 43 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category
for Lab T
estVendor Name (DERIVED)Collect
ion Dat
e:Specim
en Typ
eLab ResultForm Insta
nce
1.HEMATO
LOGY Bristol Regional Medical CEnt
er, 1 Medical Park Blv, Bristol,
TN 37620 Nov/18
/2020 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
1 Hemoglo
bin_PX1 12.
6
2 Hematocr
it_PX2 38
3 Erythrocy
tes_PX3 4.2
4
5 Platelets_
PX5 171
7 Leukocyt
es_PX7 5.3
608 Neutrophi
ls_PX608
4.4
5
609 Eosinophi
ls_PX609
0.0
0
612 Monocyte
s_PX612 0.1
5
610 Basophils
_PX610 0.0
1
611 Lymphoc
ytes_PX6
11 0.5
8 Repeating
Pages
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904842
Page 44 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Not Complete
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [Bristol Regional Medical CEnter, 1 Medical Park Blv, Bristol, TN 37620]
3.Collection Date: Nov/18/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12.6]
Not Done:
LNMT Low
[13.9]
High
[16.8]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [38]
Not Done:
LNMT Low
[41]
High
[51]
Unit
%
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904843
Page 45 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Not Complete
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [4.24]
Not Done:
LNMT Low
[4.22]
High
[5.81]
Unit
/uL
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [171]
Not Done:
LNMT Low
[150]
High
[400]
Unit
/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [5.3]
Not Done:
LNMT Low
[3.5]
High
[11.0]
Unit
/uL
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904844
Page 46 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Not Complete
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [4.45]
Not Done:
LNMT Low
[1.6]
High
[8.3]
Unit
/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.00]
Not Done:
LNMT Low
[0.0]
High
[0.60]
Unit
/uL
5 hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.15]
Not Done:
LNMT Low
[0.10]
High
[1.00]
Unit
/uL
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904845
Page 47 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Not Complete
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.01]
Not Done:
LNMT Low
[0.00]
High
[0.20]
Unit
/uL
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [0.58]
Not Done:
LNMT Low
[0.7]
High
[4.0]
Unit
/uL
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904846
Page 48 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
1.Not Applicable Record Identifier: Systolic: Diastolic:
1 Not Applicable Not Applicable Repeating Pages
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904847
Page 49 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: 1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904848
Page 50 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
1.Nov/17/2020 Record Identifier: Oxygen Saturation
1 97.0 Repeating Pages
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904849
Page 51 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Nov/17/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904850
Page 52 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxyge
n)Form Instance
1. Repeating Pages
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904851
Page 53 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904852
Page 54 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904853
Page 55 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904854
Page 56 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Ass
essmentLocation of
AssessmentImaging
MethodOverall AssessmentForm Instan
ce
1.Nov/17/202
0 CHEST X-RAY ABNORMAL
If abnormal, specify findings:
pneumonia due to COVID-19 virus:Lung opacities
most noticeable in the Right Upper Lobe
Repeating
Pages
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904855
Page 57 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Nov/17/2020
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[pneumonia due to COVID-19 virus:Lung opacities most noticeable in the
Right Upper Lobe]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904856
Page 58 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/07/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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_A1
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904857
Page 59 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Dec/07/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
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 [BRGJT9]
5.bSample ID [BRGJTB]
5.cSample ID [BRGJTC]
5.dSample ID [BRV9PC]
5.eSample ID [BRV9PD]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904858
Page 60 of 305
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904859
Page 61 of 305
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904860
Page 62 of 305
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/20/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904861
Page 63 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904862
Page 64 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904863
Page 65 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904864
Page 66 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still
ongoing?
6.Toxicity Grade:
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.
9.Is this event related to study
treatment:
10.Latest Action Taken with Study
Treatment:
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904865
Page 67 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication
given?
12.Was a Non-Drug Treatment
given?
13.What was the outcome of this
adverse event?:
14.Did the adverse event cause the
subject to be discontinued from
the study?
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904866
Page 68 of 305
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
1. Repeating
Pages
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904867
Page 69 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904868
Page 70 of 305
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904869
Page 71 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904870
Page 72 of 305
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904871
Page 73 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904872
Page 74 of 305
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identif
ierCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
1. Repeating
Pages
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904873
Page 75 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904874
Page 76 of 305
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904875
Page 77 of 305
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904876
Page 78 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904877
Page 79 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904878
Page 80 of 305
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904879
Page 81 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904880
Page 82 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904881
Page 83 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904882
Page 84 of 305
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904883
Page 85 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/14/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904884
Page 86 of 305
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904885
Page 87 of 305
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904886
Page 88 of 305
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904887
Page 89 of 305
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/25/2021
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904888
Page 90 of 305
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904889
Page 91 of 305
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/25/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904890
Page 92 of 305
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRN2DN ]
5.bSample ID [BRGJZH]
5.cSample ID [BRGJZJ]
5.dSample ID [BRGJZK]
5.eSample ID [BRV9TR]
5 fSample ID [BRV9TS]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904891
Page 93 of 305
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRN2DN]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904892
Page 94 of 305
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/25/2021 14:11
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904893
Page 95 of 305
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904894
Page 96 of 305
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/17/2021
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 [BRN2G4]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904895
Page 97 of 305
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/17/2021 14:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904896
Page 98 of 305
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904897
Page 99 of 305
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904898
Page 100 of 305
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904899
Page 101 of 305
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904900
Page 102 of 305
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904901
Page 103 of 305
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904902
Page 104 of 305
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904903
Page 105 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/20/2020
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904904
Page 106 of 305
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904905
Page 107 of 305
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Rick Whiles Approved Feb-18-2021 13:06:44 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RickWhiles, 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.
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904906
Page 108 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-28-2020 07:38:53 (UTC-05:00) Eastern
Time (US & Canada)Met all Inclusion. NO Exclusion
Not Applicable
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904907
Page 109 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-16-2020 16:56:41 (UTC-05:00) Eastern
Time (US & Canada).
FormNov-10-2020 11:43:16 (UTC-05:00) Eastern
Time (US & Canada)not completed (participant declined visiting
PCP office or urgent care, unless symptoms
worsen)
Not Done
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904908
Page 110 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-16-2020 16:56:41 (UTC-05:00) Eastern
Time (US & Canada).
1Nov-10-2020 11:43:16 (UTC-05:00) Eastern
Time (US & Canada)not completed (participant declined visiting
PCP office or urgent care, unless symptoms
worsen)
Not Done
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904909
Page 111 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-16-2020 16:56:41 (UTC-05:00) Eastern
Time (US & Canada).
2Nov-10-2020 11:43:16 (UTC-05:00) Eastern
Time (US & Canada)not completed (participant declined visiting
PCP office or urgent care, unless symptoms
worsen)
Not Done
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904910
Page 112 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-16-2020 16:56:41 (UTC-05:00) Eastern
Time (US & Canada).
3Nov-10-2020 11:43:16 (UTC-05:00) Eastern
Time (US & Canada)not completed (participant declined visiting
PCP office or urgent care, unless symptoms
worsen)
Not Done
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904911
Page 113 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-16-2020 16:56:41 (UTC-05:00) Eastern
Time (US & Canada).
4Nov-10-2020 11:43:16 (UTC-05:00) Eastern
Time (US & Canada)not completed (participant declined visiting
PCP office or urgent care, unless symptoms
worsen)
Not Done
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904912
Page 114 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Nov-16-2020 16:56:41 (UTC-05:00) Eastern
Time (US & Canada).
5Nov-10-2020 11:43:16 (UTC-05:00) Eastern
Time (US & Canada)not completed (participant declined visiting
PCP office or urgent care, unless symptoms
worsen)
Not Done
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904913
Page 115 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Nov-16-2020 16:56:41 (UTC-05:00) Eastern
Time (US & Canada).
6Nov-10-2020 11:43:16 (UTC-05:00) Eastern
Time (US & Canada)not completed (participant declined visiting
PCP office or urgent care, unless symptoms
worsen)
Not Done
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904914
Page 116 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Nov-16-2020 16:56:41 (UTC-05:00) Eastern
Time (US & Canada).
7Nov-10-2020 11:43:16 (UTC-05:00) Eastern
Time (US & Canada)not completed (participant declined visiting
PCP office or urgent care, unless symptoms
worsen)
Not Done
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904915
Page 117 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Nov-16-2020 16:56:41 (UTC-05:00) Eastern
Time (US & Canada).
8Nov-10-2020 11:43:16 (UTC-05:00) Eastern
Time (US & Canada)not completed (participant declined visiting
PCP office or urgent care, unless symptoms
worsen)
Not Done
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904916
Page 118 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Nov-16-2020 16:56:41 (UTC-05:00) Eastern
Time (US & Canada).
9Nov-10-2020 11:43:16 (UTC-05:00) Eastern
Time (US & Canada)not completed (participant declined visiting
PCP office or urgent care, unless symptoms
worsen)
Not Done
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904917
Page 119 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormNov-12-2020 08:08:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904918
Page 120 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Nov-12-2020 08:08:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904919
Page 121 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Nov-12-2020 08:08:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904920
Page 122 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Nov-12-2020 08:08:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
3Nov-10-2020 11:54:11 (UTC-05:00) Eastern
Time (US & Canada)no respiratory treatment required
Not Applicable
3Nov-10-2020 11:53:48 (UTC-05:00) Eastern
Time (US & Canada)no respiratory treatment required
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904921
Page 123 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Nov-12-2020 08:08:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904922
Page 124 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Nov-12-2020 08:08:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
5Nov-10-2020 11:55:06 (UTC-05:00) Eastern
Time (US & Canada)not applicable
5Nov-10-2020 11:54:55 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904923
Page 125 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Nov-12-2020 08:08:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
6Nov-10-2020 11:55:31 (UTC-05:00) Eastern
Time (US & Canada)not applicable
Not Applicable
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904924
Page 126 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormDec-11-2020 08:09:00 (UTC-05:00) Eastern
Time (US & Canada)Subject did not meet criteria to fill out eCRF.
Inadvertently entered.
Not Applicable
FormDec-09-2020 12:50:59 (UTC-05:00) Eastern
Time (US & Canada)HR value is not available
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904925
Page 127 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Dec-11-2020 08:09:00 (UTC-05:00) Eastern
Time (US & Canada)Subject did not meet criteria to fill out eCRF.
Inadvertently entered.
Not Applicable
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904926
Page 128 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aDec-11-2020 08:09:00 (UTC-05:00) Eastern
Time (US & Canada)Subject did not meet criteria to fill out eCRF.
Inadvertently entered.
Not Applicable
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904927
Page 129 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aDec-11-2020 08:09:00 (UTC-05:00) Eastern
Time (US & Canada)Subject did not meet criteria to fill out eCRF.
Inadvertently entered.
Not Applicable
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904928
Page 130 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aDec-11-2020 08:09:00 (UTC-05:00) Eastern
Time (US & Canada)Subject did not meet criteria to fill out eCRF.
Inadvertently entered.
Not Applicable
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904929
Page 131 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aDec-11-2020 08:09:00 (UTC-05:00) Eastern
Time (US & Canada)Subject did not meet criteria to fill out eCRF.
Inadvertently entered.
Not Applicable
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904930
Page 132 of 305
***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, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-25-2021 15:29:08 (UTC-05:00) Eastern
Time (US & Canada)All inclusion criteria met, no exclusions
Not Applicable
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904931
Page 133 of 305
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Rick Whiles Approved Feb-18-2021 13:06:44 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RickWhiles, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-17-2021 14:44:39 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Rick Whiles Approved Feb-15-2021 13:36:20 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RickWhiles, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-15-2021 09:35:36 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904932
Page 134 of 305
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
N/A
Rick Whiles Approved Feb-05-2021 17:05:41 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RickWhiles, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-05-2021 13:13:52 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Rick Whiles Approved Feb-02-2021 15:55:11 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RickWhiles, 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-25-2021 15:27:30 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904933
Page 135 of 305
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Rick Whiles Approved Dec-11-2020 18:25:43 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RickWhiles, 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-11-2020 08:07:09 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Rick Whiles Approved Dec-09-2020 17:59:33 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RickWhiles, 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-08-2020 13:09:18 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Rick Whiles Approved Dec-08-2020 13:07:11 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904934
Page 136 of 305
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, RickWhiles, 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-07-2020 13:17:26 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Rick Whiles Approved Nov-19-2020 12:25:10 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RickWhiles, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-18-2020 09:04:12 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Rick Whiles Approved Nov-17-2020 12:45:12 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904935
Page 137 of 305
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, RickWhiles, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-16-2020 15:57:00 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Rick Whiles Approved Nov-13-2020 16:53:01 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RickWhiles, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-13-2020 13:22:29 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Rick Whiles Approved Nov-12-2020 12:44:34 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904936
Page 138 of 305
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, RickWhiles, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-12-2020 08:06:03 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Rick Whiles Approved Nov-12-2020 07:56:22 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RickWhiles, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-10-2020 11:34:56 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Rick Whiles Approved Oct-30-2020 17:45:44 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904937
Page 139 of 305
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, RickWhiles, 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.
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904938
Page 140 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-28-2020 07:38:00
(UTC-05:00) Eastern
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
Aug-28-2020 07:38:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904939
Page 141 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020 07:38:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/27/2020Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904940
Page 142 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020 07:37:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10381051Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020 07:37:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1951Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020 07:38:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-28-2020 07:38:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020 07:38:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904941
Page 143 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-28-2020 07:38:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904942
Page 144 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-28-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020 07:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904943
Page 145 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020 07:40:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histo
ry Term:Chronic Pain S
yndrome
Start Date: UNK/UNK/19
92
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:40:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:40:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Chronic Pain SyndromeInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-28-2020 07:40:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1992Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904944
Page 146 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-28-2020 07:40:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-28-2020 07:40:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Diabetic Neur
opathy
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904945
Page 147 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:40:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:40:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Diabetic NeuropathyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-28-2020 07:40:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-28-2020 07:40:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-28-2020 07:42:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Facet Arthroplas
ty, cervical
Start Date: UNK/UNK/199
6Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904946
Page 148 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/1
996
1.c Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:42:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:42:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Facet Arthroplasty, cervicalInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-28-2020 07:42:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1996Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-28-2020 07:42:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1996Initial Entry
1.d
Date Location User Value Reason
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904947
Page 149 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-28-2020 07:42:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:Hyperlipide
mia
Start Date: UNK/UNK/
2002
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:42:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:42:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HyperlipidemiaInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-28-2020 07:42:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2002Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-28-2020 07:42:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904948
Page 150 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-28-2020 07:43:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:Hypertensio
n
Start Date: UNK/UNK/
2010
Ongoing: YESInitial Entry
1.e Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:43:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:43:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-28-2020 07:43:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-28-2020 07:43:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904949
Page 151 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-28-2020 07:44:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6
Medical History
Term:Insomnia
Start Date: UNK/UNK/
2010
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:44:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:44:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
InsomniaInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-28-2020 07:44:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-28-2020 07:44:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904950
Page 152 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-01-2020 07:38:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:7
Medical Hist
ory Term:Lumbar Radi
culopathy
Start Date: UNK/UNK/1
996
Ongoing: YESTranscription Error
Aug-28-2020 07:45:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Histo
ry Term:Lumbar Ridi
culopathy
Start Date: UNK/UNK/1
996
Ongoing: YESInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904951
Page 153 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:45:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020
10:46:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Clos
edDiscrepancy has
been closed.
Sep-01-2020
07:38:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredTranscription Error
Sep-01-2020
07:38:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
Lumba
r Radic
ulopat
hyTranscription Error
Aug-28-2020
18:02:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Ope
nedClarify LUMBAR
RIDICULOPATHY
as follows...should
spelling be
LUMBAR
RADICULOPATHY
and edit term or
further clarify and
edit term. Thank
you.
Aug-28-2020 ACV0PFEINFP6000 Data E Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0904952
Page 154 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
07:45:19
(UTC-05:00)
Eastern Time
(US &
Canada)ntry:
Lumba
r Ridic
ulopat
hy
1.g Start Date:
Date Location User Value Reason
Aug-28-2020 07:45:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1996Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-28-2020 07:45:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-28-2020 07:45:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Hist
ory Term:Osteoarthritis,m
ultiple sites
Start Date: UNK/UNK/201
4
Ongoing: YESInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0904953
Page 155 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:45:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:45:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Osteoarthritis,multiple sitesInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-28-2020 07:45:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-28-2020 07:45:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-28-2020 07:46:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History
Term:Severe Obes
ity
Start Date: UNK/UNK/
2000
Ongoing: YESInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904954
Page 156 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:46:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:46:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Severe ObesityInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-28-2020 07:46:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-28-2020 07:46:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904955
Page 157 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.j
Date Location User Value Reason
Aug-28-2020 07:56:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:10
Medical Hist
ory Term:Left Hand Tri
gger Finger
Start Date: Feb/UNK/202
0
Ongoing: YESTranscription Error
Aug-28-2020 07:46:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:10
Medical Hist
ory Term:Left Hand Tri
gger Finger
Start Date: UNK/UNK/20
20
Ongoing: YESInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904956
Page 158 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:46:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:46:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Left Hand Trigger FingerInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-28-2020 07:56:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-28-2020 07:56:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/UNK/2020Transcription Error
Aug-28-2020 07:54:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after
or equal to the first
vaccination date
27/Aug/2020.
Please review and
update as
appropriate.
Aug-28-2020 07:46:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2020Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-28-2020 07:46:55
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904957
Page 159 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
1.k
Date Location User Value Reason
Aug-28-2020 07:56:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:11
Medical Hist
ory Term:Right Hand Tr
igger Finger
Start Date: Feb/UNK/202
0
Ongoing: YESTranscription Error
Aug-28-2020 07:47:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:11
Medical Hist
ory Term:Right Hand Tr
igger Finger
Start Date: UNK/UNK/20
20
Ongoing: YESInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904958
Page 160 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.k Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:47:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:47:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Right Hand Trigger FingerInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-28-2020 07:56:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-28-2020 07:56:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/UNK/2020Transcription Error
Aug-28-2020 07:54:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Start Date is after
or equal to the first
vaccination date
27/Aug/2020.
Please review and
update as
appropriate.
Aug-28-2020 07:47:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2020Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-28-2020 07:47:28
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904959
Page 161 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
1.l
Date Location User Value Reason
Aug-28-2020 07:48:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:12
Medical Histo
ry Term:Type 2 Diabete
s Mellitus
Start Date: UNK/UNK/20
01
Ongoing: YESInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904960
Page 162 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.l Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:48:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:48:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type 2 Diabetes MellitusInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-28-2020 07:48:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2001Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-28-2020 07:48:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Aug-28-2020 07:48:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:13
Medical Hist
ory Term:Right Knee Rep
lacement
Start Date: UNK/UNK/201
8Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904961
Page 163 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/
2018
1.m Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:48:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:48:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Right Knee ReplacementInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-28-2020 07:48:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-28-2020 07:48:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.n
Date Location User Value Reason
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904962
Page 164 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-28-2020 07:49:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:14
Medical Hist
ory Term:Left Knee Repl
acemnent
Start Date: Dec/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/
2019Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904963
Page 165 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.n Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:49:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:49:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Left Knee ReplacemnentInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-28-2020 07:49:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/UNK/2019Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-28-2020 07:49:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.o
Date Location User Value Reason
Aug-28-2020 07:50:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:15
Medical Hist
ory Term:Lumbar Vertebr
al FusionInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904964
Page 166 of 305
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/199
5
Ongoing: NO
End Date:
UNK/UNK/
1995
1.o Line/MH Number:
Date Location User Value Reason
Aug-28-2020 07:50:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020 07:50:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Lumbar Vertebral FusionInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-28-2020 07:50:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-28-2020 07:50:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1995Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904965
Page 167 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020 07:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020 07:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
245.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020 07:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-28-2020 07:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
69.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020 07:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904966
Page 168 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-28-2020 07:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
36.3Initial Entry
7.a
Date Location User Value Reason
Aug-28-2020 07:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 98.5
Temperature Uni
t:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020 07:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020 07:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020 07:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904967
Page 169 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-28-2020 07:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904968
Page 170 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020 07:51:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020 07:51:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
243871Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904969
Page 171 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 07:51:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 07:51:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 07:51:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 07:51:12
(UTC-05:00) Eastern
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.
Aug-28-2020 07:51:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904970
Page 172 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-28-2020 07:51:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN62TYInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 07:51:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN62TYInitial Entry
5.b
Date Location User Value Reason
Aug-28-2020 07:51:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN62TZInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020 07:51:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN62TZInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020 07:51:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN62V0Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-28-2020 07:51:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN62V0Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904971
Page 173 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d
Date Location User Value Reason
Aug-28-2020 07:51:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLB4H4Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-28-2020 07:51:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLB4H4Initial Entry
5.e
Date Location User Value Reason
Aug-28-2020 07:52:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLB4H5Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-28-2020 07:52:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLB4H5Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904972
Page 174 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 07:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 07:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 07:52:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 07:52:38
(UTC-05:00) Eastern
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.
Aug-28-2020 07:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/27/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904973
Page 175 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-28-2020 07:52:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN6327Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 07:52:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN6327Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904974
Page 176 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-28-2020 07:54:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020 07:54:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020 07:54:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-28-2020 07:54:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020 16:49Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020 07:54:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904975
Page 177 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-28-2020 07:54:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-28-2020 07:54:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-28-2020 07:54:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-28-2020 07:54:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904976
Page 178 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-28-2020 07:54:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904977
Page 179 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020 15:13:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904978
Page 180 of 305
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 15:15:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020 15:13:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 98.6
Temperature Uni
t:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 15:13:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-18-2020 15:13:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.6Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904979
Page 181 of 305
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020 15:13:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-18-2020 15:13:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904980
Page 182 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 15:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 15:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020 15:14:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-18-2020 15:14:07
(UTC-05:00) Eastern
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-18-2020 15:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904981
Page 183 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020 15:14:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN636PInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020 15:14:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN636PInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904982
Page 184 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020 15:15:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 15:15:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 15:15:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-18-2020 15:15:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020 14:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 15:15:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904983
Page 185 of 305
***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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020 15:15:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-18-2020 15:15:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020 15:15:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-18-2020 15:15:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0904984
Page 186 of 305
***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, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020 15:26:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904985
Page 187 of 305
***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, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 15:26:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 15:26:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 15:26:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-20-2020 15:26:27
(UTC-05:00) Eastern
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-20-2020 15:26:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904986
Page 188 of 305
***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, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-20-2020 15:26:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRV9JCInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 15:26:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRV9JCInitial Entry
5.b
Date Location User Value Reason
Oct-20-2020 15:26:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRV9JDInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020 15:26:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRV9JDInitial Entry
5.c
Date Location User Value Reason
Oct-20-2020 15:27:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPVFV3Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-20-2020 15:27:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPVFV3Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904987
Page 189 of 305
***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, Locked, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d
Date Location User Value Reason
Oct-20-2020 15:27:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPVFV4Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-20-2020 15:27:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPVFV4Initial Entry
5.e
Date Location User Value Reason
Oct-20-2020 15:27:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPVFV5Initial Entry
5.e Sample ID
Date Location User Value Reason
Oct-20-2020 15:27:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPVFV5Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904988
Page 190 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-10-2020 11:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-10-2020 11:34:54
(UTC-05:00) Eastern
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.
Nov-10-2020 11:34:54
(UTC-05:00) Eastern
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.
Nov-10-2020 11:34:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/9/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-10-2020 11:34:54
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904989
Page 191 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904990
Page 192 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/9/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/7/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-05-2021 15:19:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-05-2021 13:13:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Feb-05-2021 13:13:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Re
solved:
Nov/25/2020Changed
Information
Feb-04-2021 18:38:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened CLINQUERY:
Please work with
your site monitor
to update
appropriately.
Feb-03-2021 15:32:40 ACV0PFEINFP6000 Query 1: Answered Changing the
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (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) (6)
FDA-CBER-2021-5683-0904991
Page 193 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern
Time (US & Canada)answer to NO will
delete the initial
entry in the
Potential
COVID-19 InForm
page. Therefore, it
is not optional.
Please review.
Thank you
Feb-03-2021 14:04:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened CLINQUERY:
Query is in
reference to this
COV ILL SOD
CRF field, not AE
CRF. If symptoms
have ended, please
update field of
‘Symptoms
Ongoing’ to ‘NO’
and add Date of
Last Symptom
Resolved on the
CRF.
Feb-03-2021 12:21:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered The symptoms
resolution date was
11/25/2020.
InForm as a
system does not
allow to enter the
AE follow up.
Please accept this
response.
Feb-02-2021 08:26:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
Please clarify
whether the
reported symptoms
are still ongoing?
If symptoms have
ended, please
update ‘Symptoms
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904992
Page 194 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing’ on to
‘NO’ and add Date
of Last Symptom
Resolved on the
CRF.
Feb-01-2021 14:55:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Candidate CLINQUERY:
Please clarify
whether the
reported symptoms
are still ongoing?
If symptoms have
ended, please
update ‘Symptoms
Ongoing’ on to
‘NO’ and add Date
of Last Symptom
Resolved on the
CRF.
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Dec-08-2020
13:36:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEV
ER
Symptom Pr
esent:YESSubject had no fever on
11/09/20. Subject visited ER
on 11/17/20 due to increased
shortness of breath with
chest tightness,
fever,increased cough
(non-productive). Therefore,
report has been updated to
capture new
information(hospitalization).
Nov-10-2020
11:40:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEV
ERInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904993
Page 195 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Symptom Pr
esent:NO
4.a Symptoms:
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Dec-08-2020
13:36:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESSubject had no fever on
11/09/20. Subject visited ER
on 11/17/20 due to increased
shortness of breath with
chest tightness,
fever,increased cough
(non-productive). Therefore,
report has been updated to
capture new
information(hospitalization).
Nov-10-2020
11:40:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCR
EASED COUG
H
Symptom
Present:YESInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904994
Page 196 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.b Symptoms:
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED CO
UGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Dec-08-2020
13:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR INCRE
ASED SHORTNE
SS OF BREATH
Sympt
om Pre
sent:YESSubject had no
shortness of breath
on 11/09/20.
Subject visited ER
on 11/17/20 due to
increased shortness
of breath with chest
tightness,
fever,increased
cough
(non-productive).
Therefore, report
has been updated to
capture new
information.
Nov-10-2020
11:40:54 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
Sympt
oms:NEW OR INCRE
ASED SHORTNE
SS OF BREATH
Sympt
om Pre
sent:NOInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904995
Page 197 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.c Symptoms:
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SH
ORTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Dec-08-2020
13:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESSubject had no
shortness of breath
on 11/09/20.
Subject visited ER
on 11/17/20 due to
increased shortness
of breath with chest
tightness,
fever,increased
cough
(non-productive).
Therefore, report
has been updated to
capture new
information.
Nov-10-2020
11:40:54 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILL
S
Symptom Present
:NOInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904996
Page 198 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.d Symptoms:
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE
PAIN
Sympto
m Prese
nt:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MU
SCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904997
Page 199 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.f
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW LOSS OF
TASTE OR SME
LL
Sympto
m Presen
t:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR
SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCRE
ASED SORE TH
ROAT
Sympto
m Prese
nt:YESInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904998
Page 200 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.g Symptoms:
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SO
RE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHE
A
Symptom Prese
nt:NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.i
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904999
Page 201 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITIN
G
Symptom Prese
nt:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-10-2020 11:40:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Nov-10-2020 11:41:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - Ot
her:chest tightn
essInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Nov-10-2020 11:41:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
chest tightnessInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0905000
Page 202 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-16-2020 17:00:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0905001
Page 203 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-16-2020 17:00:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
Nov-16-2020 16:56:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 11:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-16-2020 17:00:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
Nov-16-2020 16:56:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 11:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-16-2020 17:00:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
Nov-16-2020 16:56:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0905002
Page 204 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-10-2020 11:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-16-2020 17:00:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SY
NDROME CORONAVIRUS
2Initial Entry
Nov-16-2020 16:56:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 11:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Nov-16-2020 17:00:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTI
C TESTInitial Entry
Nov-16-2020 16:56:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 11:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
Nov-16-2020 17:00:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0905003
Page 205 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-16-2020 16:56:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 11:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7. Test Result:
Date Location User Value Reason
Nov-16-2020 17:00:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
POSITIVEInitial Entry
Nov-16-2020 16:56:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 11:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Nov-16-2020 16:56:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Nov-10-2020 11:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User ValueReason
Nov-18-2020
11:09:01
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 Query
1: Clo
sedResponse
satisfies query
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905004
Page 206 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Canada)
Nov-18-2020
09:04:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dcorrected per
query
Nov-18-2020
09:04:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Holog
ic Apt
ima S
ARS-
CoV-
2 assa
ycorrected per
query
Nov-18-2020
07:43:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query
1: Op
enedAs per FDA
List of Trade
names and
CRF CR, data
should be
updated as
"Hologic
Aptima
SARS-CoV-2
assay",
Kindly update
data as
requested,
else clarify,
Thank you.
Nov-16-2020
17:00:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Aptim
a, Hol
ogicInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0905005
Page 207 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-16-2020
16:56:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:Initial Entry
Nov-10-2020
11:43:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Not D
oneInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905006
Page 208 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: 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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-10-2020 11:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-10-2020 11:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-10-2020 11:46:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-10-2020 11:44:40
(UTC-05:00) Eastern
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-10-2020 11:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/9/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0905007
Page 209 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: 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: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-10-2020 11:46:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: CV24085Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-10-2020 11:46:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CV24085Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0905008
Page 210 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-10-2020 11:47:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-10-2020 11:47:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-16-2020 18:08:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-16-2020 16:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Closed Close Auto Query
Nov-16-2020 16:53:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened 'Sample
Collected?' is
marked as No and
'If no sample was
collected or
sample was not
collected
according to
protocol, please
provide reason' is
missing. Please
review and update
as appropriate.
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0905009
Page 211 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-16-2020 16:53:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-16-2020 16:53:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NONew Information
Nov-16-2020 15:59:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Nov-16-2020 15:57:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-16-2020 15:57:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of Collection
10/Nov/2020 is
different from
Date of Visit
09/Nov/2020.
Please review and
update as
appropriate, else
clarify.
Nov-16-2020 15:57:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/10/2020New Information
Nov-10-2020 11:47:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 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
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0905010
Page 212 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-16-2020 16:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Self swab collected on Nov
09, 2020Initial Entry
Nov-16-2020 16:53:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription
Error
Nov-16-2020 15:59:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-16-2020 15:59:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Self swab completed on No
v 09,2020.Local lab test co
mpleted on Nov 10,2020.Transcription
Error
Nov-16-2020 15:58:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Self swab completed on No
v 09, 2020.Local lab test co
mpleted on Nov 10,2020.Transcription
Error
Nov-16-2020 15:58:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Entered text has
either a carriage
return (line break)
or extra spaces at
the end of the text
or between words.
Please correct by
removing all data
in the field and
re-enter without
adding extra
spaces or using
enter or tab keys.
Nov-16-2020 15:58:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Self swab completed on No
v 09, 2020. Local lab test co
mpleted on Nov 10,2020.New Information
Nov-10-2020 11:47:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
self swab is completed on N
ov 09, 2020 and delivered toInitial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0905011
Page 213 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
the office on Nov 10,2020.
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-0905012
Page 214 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Nov-10-2020 11:53:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practition
er:SPECI
ALIST
Occurrence of Visi
ts or Contacts:NOInitial Entry
Nov-10-2020 11:49:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practition
er:SPECI
ALIST
Occurrence of Visi
ts or Contacts:Initial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-10-2020 11:49:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-10-2020 11:53:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Dec-08-2020
13:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Pra
ctitioner:EMERGEN
CY ROOMChange of severity:
Subject visited ER
on 11/17/20 due to
increased shortness
of breath with chest
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0905013
Page 215 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Occurrence
of Visits or
Contacts:YES
Number of
Visits or Co
ntacts:
1tightness,
fever,increased
cough
(non-productive)
Nov-10-2020
11:53:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practi
tioner:EMERGE
NCY RO
OM
Occurrence of
Visits or Cont
acts:NOInitial Entry
Nov-10-2020
11:49:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practi
tioner:EMERGE
NCY RO
OM
Occurrence of
Visits or Cont
acts:Initial Entry
090177e196ae2f47\Final\Final On: 01-Apr-2021 03:39 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0905014
Page 216 of 305
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Nov/09/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1038 Site Name: (1038) Holston Medical Group
Subject No: 10381051 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-10-2020 11:49:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Dec-08-2020 13:24:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Number of Visits or Conta
cts:
1Change of severity:
Subject visited ER
on 11/17/20 due to
increased shortness
of breath with chest
tightness,
fever,increased
cough
(non-productive)
Nov-10-2020
11:53:00 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Nov-10-2020 11:53:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Typ
…[truncated]