125742 S1 M5 CRF c4591001 1044 10441194

Document text

Page 1 of 679
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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 version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909909
Page 2 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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
Oct/18/2020
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909910
Page 3 of 679
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10441194]
2.Birth Date: /1964
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909911
Page 4 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/18/2020
2.Erroneous Visit
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909912
Page 5 of 679
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909913
Page 6 of 679
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909914
Page 7 of 679
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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:[Latex Allergy]
Start Date: UNK/UNK/1990
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Naratriptan Allergy]
Start Date: UNK/UNK/1987
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[NSAIDS Allergy]
Start Date: UNK/UNK/1995
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bactrim Allergy]
Start Date: UNK/UNK/1980
Ongoing: YES
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909915
Page 8 of 679
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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:[Nitrofurantoin Allergy]
Start Date: UNK/UNK/1980
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tizanidine Allergy]
Start Date: UNK/UNK/1987
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cervical Radiculopathy]
Start Date: UNK/UNK/1990
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left Shoulder Pain]
Start Date: Jun/UNK/2019
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Migraine Headaches]
Start Date: UNK/UNK/1987
Ongoing: YES
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909916
Page 9 of 679
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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:[Asthma]
Start Date: UNK/UNK/1985
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Rosacea]
Start Date: UNK/UNK/1990
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: UNK/UNK/2000
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Arthritis (General)]
Start Date: UNK/UNK/1990
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909917
Page 10 of 679
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909918
Page 11 of 679
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/18/2020
2.Weight: [68.9]
3.Unit: kg
4.Height: [172.7]
5.Unit: cm
6.Body Mass Index: [23.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909919
Page 12 of 679
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/18/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909920
Page 13 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/18/2020
2.Randomization Number: [270232]
3.Randomization Group: [ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909921
Page 14 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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/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 [BN66ZH]
5.bSample ID [BRVKLY]
5.cSample ID [BRVKM5]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909922
Page 15 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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:
Oct/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 [BN66Z9]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909923
Page 16 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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: Oct/18/2020 11:17
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909924
Page 17 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909925
Page 18 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909926
Page 19 of 679
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Nov/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909927
Page 20 of 679
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/6/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909928
Page 21 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/6/2020
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 [BPW0GN]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909929
Page 22 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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: Nov/6/2020 10:24
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909930
Page 23 of 679
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909931
Page 24 of 679
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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 [BR6HXZ]
5.bSample ID [BRVL1Z]
5.cSample ID [BRVL3L]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909932
Page 25 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/21/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909933
Page 26 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/21/2021
2.Date of First Symptom Started: Jan/21/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/24/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909934
Page 27 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909935
Page 28 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jan/24/20
21 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909936
Page 29 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/24/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: INDETERMINATE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909937
Page 30 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Jan/21/2021
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 [CV35672]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909938
Page 31 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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:[as per protocol]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909939
Page 32 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909940
Page 33 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909941
Page 34 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909942
Page 35 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909943
Page 36 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909944
Page 37 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909945
Page 38 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined I
dentifierTest:Result:
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909946
Page 39 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909947
Page 40 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909948
Page 41 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909949
Page 42 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909950
Page 43 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one Repeating
Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909951
Page 44 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909952
Page 45 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909953
Page 46 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909954
Page 47 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909955
Page 48 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909956
Page 49 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909957
Page 50 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Systolic: Diastolic:
Not Done  Not Done  Not Done Repeating Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909958
Page 51 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909959
Page 52 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Oxygen Saturation
Not Done  Not Done Repeating Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909960
Page 53 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909961
Page 54 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909962
Page 55 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909963
Page 56 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909964
Page 57 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909965
Page 58 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909966
Page 59 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909967
Page 60 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909968
Page 61 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Mar/10/2021
2.Date of First Symptom Started: Mar/7/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Mar/7/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909969
Page 62 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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: [ataxia]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909970
Page 63 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909971
Page 64 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909972
Page 65 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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:
Mar/10/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RR27717]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909973
Page 66 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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:[as per protocol]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909974
Page 67 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909975
Page 68 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909976
Page 69 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909977
Page 70 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909978
Page 71 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909979
Page 72 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909980
Page 73 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined I
dentifierTest:Result:
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne 
Not Done  Not Do
ne Not Do
ne Repeating
Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909981
Page 74 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909982
Page 75 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909983
Page 76 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909984
Page 77 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909985
Page 78 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one Repeating
Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909986
Page 79 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909987
Page 80 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909988
Page 81 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909989
Page 82 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909990
Page 83 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909991
Page 84 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909992
Page 85 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Systolic: Diastolic:
Not Done  Not Done  Not Done Repeating Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909993
Page 86 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909994
Page 87 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Oxygen Saturation
Not Done  Not Done Repeating Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909995
Page 88 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909996
Page 89 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909997
Page 90 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Done
[ ]Comments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909998
Page 91 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909999
Page 92 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910000
Page 93 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910001
Page 94 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Mar/10/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910002
Page 95 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/26/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910003
Page 96 of 679
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Feb/26/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/26/2021
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 [BRL51G]
5.bSample ID [BS17V7]
5.cSample ID [BS17TX]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910004
Page 97 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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:
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910005
Page 98 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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 [ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910006
Page 99 of 679
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
 1. ADVERSE E
VENT 1  injection site pa
in Oct/18/2020 UN
K:UNK NO
End Date Time:
Oct/19/2020 UNK:U
NK
 Repeating
Pages
 2. ADVERSE E
VENT 2  injection site pa
in Nov/6/2020 UN
K:UNK NO
End Date Time:
Nov/7/2020 UNK:UN
K
 Repeating
Pages
 3. ADVERSE E
VENT 3  laceration right
hand Feb/6/2021 UN
K:UNK YES  Repeating
Pages
 4. ADVERSE E
VENT 4  dry mouth  Feb/8/2021 UN
K:UNK YES  Repeating
Pages
 5. ADVERSE E
VENT 5  Unsteadiness o
n feet Feb/7/2021 UN
K:UNK YES  Repeating
Pages
 6. ADVERSE E
VENT 6  fatigue  Feb/8/2021 UN
K:UNK YES  Repeating
Pages
 7. ADVERSE E
VENT 7  Severe Fatigue  Feb/7/2021 UN
K:UNK NO
End Date Time:
Feb/7/2021 UNK:UN
K
 Repeating
Pages
 8. ADVERSE E
VENT 8  injection site Er
ythema Feb/26/2021 UN
K:UNK NO
End Date Time:
Feb/27/2021 UNK:U
NK
 Repeating
Pages
 9. DELETED ADVERSE E
VENT 9  Ataxia  Mar/7/2021 UN
K:UNK NO
End Date Time:
Mar/7/2021 UNK:UN
K
 Repeating
Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910007
Page 100 of 679
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[injection site pain]
4.Start Date Time: Oct/18/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/19/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910008
Page 101 of 679
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910009
Page 102 of 679
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[injection site pain]
4.Start Date Time: Nov/6/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/7/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910010
Page 103 of 679
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910011
Page 104 of 679
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[laceration right hand]
4.Start Date Time: Feb/6/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910012
Page 105 of 679
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910013
Page 106 of 679
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[dry mouth]
4.Start Date Time: Feb/8/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unk]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910014
Page 107 of 679
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910015
Page 108 of 679
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Unsteadiness on feet]
4.Start Date Time: Feb/7/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[opiod overdose effects]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910016
Page 109 of 679
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910017
Page 110 of 679
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[fatigue]
4.Start Date Time: Feb/8/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unk]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910018
Page 111 of 679
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910019
Page 112 of 679
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Severe Fatigue]
4.Start Date Time: Feb/7/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/7/2021 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
Did this serious event result in death?
Did this serious event require or prolong hospitalization?
Did this serious event result in persistent or significant disability/incapacity?
Is this serious event life threatening?
YES
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[opioids overdose]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910020
Page 113 of 679
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021132328]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910021
Page 114 of 679
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[injection site Erythema]
4.Start Date Time: Feb/26/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/27/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910022
Page 115 of 679
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910023
Page 116 of 679
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Ataxia]
4.Start Date Time: Mar/7/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/7/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unk]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910024
Page 117 of 679
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910025
Page 118 of 679
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910026
Page 119 of 679
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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[ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910027
Page 120 of 679
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910028
Page 121 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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: //
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910029
Page 122 of 679
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910030
Page 123 of 679
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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?
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910031
Page 124 of 679
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910032
Page 125 of 679
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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?
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910033
Page 126 of 679
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910034
Page 127 of 679
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910035
Page 128 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910036
Page 129 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910037
Page 130 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910038
Page 131 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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:
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910039
Page 132 of 679
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910040
Page 133 of 679
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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?
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910041
Page 134 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910042
Page 135 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910043
Page 136 of 679
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Dec/7/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910044
Page 137 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910045
Page 138 of 679
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910046
Page 139 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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: [ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910047
Page 140 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/4/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910048
Page 141 of 679
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910049
Page 142 of 679
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910050
Page 143 of 679
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910051
Page 144 of 679
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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
Feb/5/2021
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910052
Page 145 of 679
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910053
Page 146 of 679
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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
:Feb/5/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910054
Page 147 of 679
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/5/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910055
Page 148 of 679
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/5/2021
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 [BRJZBB]
5.bSample ID [BS17M7]
5.cSample ID [BS17NW]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910056
Page 149 of 679
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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/5/2021
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 [BRJZF6]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910057
Page 150 of 679
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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/5/2021 13:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910058
Page 151 of 679
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021
2.Erroneous Visit
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910059
Page 152 of 679
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/26/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910060
Page 153 of 679
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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/26/2021
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 [BRL52G]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910061
Page 154 of 679
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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/26/2021 11:01
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910062
Page 155 of 679
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910063
Page 156 of 679
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910064
Page 157 of 679
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910065
Page 158 of 679
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910066
Page 159 of 679
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910067
Page 160 of 679
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910068
Page 161 of 679
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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: [ ]
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910069
Page 162 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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 Dec/7/2020
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910070
Page 163 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910071
Page 164 of 679
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 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
Aaron Hartman  Approved Mar-12-2021 12:20:22 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AaronHartman, 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.
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0910072
Page 165 of 679
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-18-2020 13:32:47 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0910073
Page 166 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-27-2021 17:13:19 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0910074
Page 167 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-27-2021 17:13:19 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0910075
Page 168 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/21/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-27-2021 17:13:19 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
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ItemDate User Comment
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ItemDate User Comment
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ItemDate User Comment
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
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Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
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Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
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2Jan-28-2021 00:36:42 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
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3Jan-28-2021 00:36:42 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0910122
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
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4Jan-28-2021 00:36:42 (UTC-05:00) Eastern
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FDA-CBER-2021-5683-0910123
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
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FDA-CBER-2021-5683-0910124
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***Confidential***
Header Text: c4591001
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
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Subject No: 10441194 Subject Initials: ---
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FDA-CBER-2021-5683-0910125
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
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Subject No: 10441194 Subject Initials: ---
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
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ItemDate User Comment
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
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ItemDate User Comment
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Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
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ItemDate User Comment
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
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ItemDate User Comment
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
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Subject No: 10441194 Subject Initials: ---
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ItemDate User Comment
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FDA-CBER-2021-5683-0910133
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
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ItemDate User Comment
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FDA-CBER-2021-5683-0910134
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
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Back to Form
ItemDate User Comment
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Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0910135
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
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Back to Form
ItemDate User Comment
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Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0910136
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Back to Form
ItemDate User Comment
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Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0910137
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Back to Form
ItemDate User Comment
5.dJan-28-2021 00:36:42 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0910138
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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ItemDate User Comment
5.dJan-28-2021 00:36:42 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0910139
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10441194 Subject Initials: ---
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ItemDate User Comment
5.eJan-28-2021 00:36:42 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3e5f\Final\Final On: 01-Apr-2021 04:53 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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FDA-CBER-2021-5683-0910170
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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***Confidential***
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FormJan-28-2021 00:37:36 (UTC-05:00) Eastern
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Subject No: 10441194 Subject Initials: ---
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FormJan-28-2021 00:37:52 (UTC-05:00) Eastern
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Site No: 1044 Site Name: (1044) Virginia Research Center
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1Jan-28-2021 00:37:52 (UTC-05:00) Eastern
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Back to Form
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2Jan-28-2021 00:37:52 (UTC-05:00) Eastern
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Back to Form
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3Jan-28-2021 00:37:52 (UTC-05:00) Eastern
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
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Back to Form
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4Jan-28-2021 00:37:52 (UTC-05:00) Eastern
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FDA-CBER-2021-5683-0910181
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
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Back to Form
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5Jan-28-2021 00:37:52 (UTC-05:00) Eastern
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
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Back to Form
ItemDate User Comment
6Jan-28-2021 00:37:52 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10441194 Subject Initials: ---
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Back to Form
ItemDate User Comment
FormJan-28-2021 00:38:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-28-2021 00:38:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0910185
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
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Subject No: 10441194 Subject Initials: ---
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Back to Form
ItemDate User Comment
2Jan-28-2021 00:38:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0910186
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10441194 Subject Initials: ---
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Back to Form
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3Jan-28-2021 00:38:07 (UTC-05:00) Eastern
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FDA-CBER-2021-5683-0910187
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-28-2021 00:38:07 (UTC-05:00) Eastern
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FDA-CBER-2021-5683-0910188
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Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
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Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormMar-10-2021 16:36:51 (UTC-05:00) Eastern
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FDA-CBER-2021-5683-0910189
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Visit: POT_COVID_ILL 2 - Unscheduled Visit
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Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Mar-10-2021 16:36:51 (UTC-05:00) Eastern
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FDA-CBER-2021-5683-0910190
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Visit: POT_COVID_ILL 2 - Unscheduled Visit
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Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Mar-10-2021 16:36:51 (UTC-05:00) Eastern
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FDA-CBER-2021-5683-0910191
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Visit: POT_COVID_ILL 2 - Unscheduled Visit
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Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
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FDA-CBER-2021-5683-0910192
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Visit: POT_COVID_ILL 2 - Unscheduled Visit
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Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
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FDA-CBER-2021-5683-0910193
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Mar-10-2021 16:36:51 (UTC-05:00) Eastern
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FDA-CBER-2021-5683-0910194
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Mar-10-2021 16:36:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0910195
Page 288 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Mar-10-2021 16:36:51 (UTC-05:00) Eastern
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FDA-CBER-2021-5683-0910196
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Mar-10-2021 16:36:51 (UTC-05:00) Eastern
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FDA-CBER-2021-5683-0910197
Page 290 of 679
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Mar-10-2021 16:36:51 (UTC-05:00) Eastern
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FDA-CBER-2021-5683-0910198
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***Confidential***
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Visit: POT_COVID_ILL 2 - Unscheduled Visit
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Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
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FDA-CBER-2021-5683-0910199
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
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Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441194 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Mar-10-2021 16:38:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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FDA-CBER-2021-5683-0910200
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***Confidential***
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Visit: POT_COVID_ILL 2
…[truncated]