125742 S1 M5 CRF c4591001 1019 10191226

Document text

Page 1 of 382
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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 version08 SEP 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897198
Page 2 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/23/2020
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897199
Page 3 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10191226]
2.Birth Date: /1973
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897200
Page 4 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897201
Page 5 of 382
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897202
Page 6 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/23/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897203
Page 7 of 382
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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:[Glaucoma]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Myopia]
Start Date: UNK/UNK/1987
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Presbyopia]
Start Date: UNK/UNK/2000
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Heartburn]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897204
Page 8 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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:[Obesity]
Start Date: UNK/UNK/1994
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Nephrolithiasis]
Start Date: UNK/UNK/1991
Ongoing: NO
End Date:
UNK/UNK/1991
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Herpes zoster]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Intermittent leg cramps]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897205
Page 9 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Recurrent back pain]
Start Date: UNK/UNK/1991
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic rhinitis]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897206
Page 10 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897207
Page 11 of 382
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
2.Weight: [229.9]
3.Unit: LB
4.Height: [66.5]
5.Unit: in
6.Body Mass Index: [36.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: EAR
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897208
Page 12 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/23/2020
2.Randomization Number: [97847]
3.Randomization Group: [ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897209
Page 13 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
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 [BP98GP]
5.bSample ID [BPRWTW]
5.cSample ID [BPRWTX]
5.dSample ID [BPRWTY]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897210
Page 14 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
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 [BP98MR]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897211
Page 15 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/23/2020 12:54
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897212
Page 16 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897213
Page 17 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897214
Page 18 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [99.1]
Unit: F
Temperature Location: EAR
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897215
Page 19 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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/14/2020
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 [BP98SP]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897216
Page 20 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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/14/2020 12:33
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897217
Page 21 of 382
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/11/2020
2.Erroneous Visit
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897218
Page 22 of 382
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/11/2020
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 [BR85VT]
5.bSample ID [BRZC80]
5.cSample ID [BRZC81]
5.dSample ID [BRZC82]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897219
Page 23 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/29/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897220
Page 24 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/29/2020
2.Date of First Symptom Started: Dec/28/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/23/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
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
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897221
Page 25 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897222
Page 26 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of
Collectio
nSpecimen T
ypeSpecimen Coll
ection Locatio
nAssay Code and Descriptio
nDevice TypeForm Instan
ce
 1.Jan/10/20
21 SWABBED
MATERIAL
 NASOPHARY
NX SEVERE ACUTE RESP SY
NDROME CORONAVIRUS
2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897223
Page 27 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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/10/2021
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: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT UNKNOWN]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897224
Page 28 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[Subject threw away their self swab kit. Did not have a way to resupply
them in a timely manner.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897225
Page 29 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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:[Subject lives too far away to come into office.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897226
Page 30 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Queries, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897227
Page 31 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete, Queries, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19
illness?
NO
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897228
Page 32 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Hospitalization CategoryHospitalization Ter
mAdmission Dat
eOngoing Form Instance
 1.HOSPITALIZATION STATU
S HOSPITAL   Jan/13/2021  NO
Discharge Dat
e:
Jan/23/2021
 Repeating Pages
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897229
Page 33 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Jan/13/2021
4.Ongoing? NO
Discharge Date:
Jan/23/2021
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897230
Page 34 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Ide
ntifierCon Non-Drug Treatments P
re-specifiedTreatment Treatment Start DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applic
able Not Applic
able Not Applic
able Repeating
Pages
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897231
Page 35 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897232
Page 36 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[COVID-19 Illness]
Date of Diagnosis:
Jan/10/2021
3.Toxicity Grade: 3
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897233
Page 37 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Ev
ent:Subcategory of Clinical E
ventDiagnosis Obtai
nedToxicity Gra
deForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicab
le Repeating
Pages
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897234
Page 38 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897235
Page 39 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Applicab
le Not Appl
icable Not Appli
cable Not Appl
icable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable 
Not Applicable  Not Appl
icable Not Appl
icable Repeating
Pages
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897236
Page 40 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897237
Page 41 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897238
Page 42 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897239
Page 43 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897240
Page 44 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category fo
r Lab TestVendor Name
(DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Applica
ble Not Applicable
 Not Appl
icable Not App
licable Sponsor-Defi
ned IdentifierTest:Result:
Not Applicabl
e Not App
licable Not App
licable 
Not Applicabl
e Not App
licable Not App
licable 
Not Applicabl
e Not App
licable Not App
licable 
Not Applicabl
e Not App
licable Not App
licable 
Not Applicabl
e Not App
licable Not App
licable 
Not Applicabl
e Not App
licable Not App
licable 
Not Applicabl
e Not App
licable Not App
licable 
Not Applicabl
e Not App
licable Not App
licable 
Not Applicabl
e Not App
licable Not App
licable 
Not Applicabl
e Not App
licable Not App
licable Repeating
Pages
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897241
Page 45 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897242
Page 46 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897243
Page 47 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897244
Page 48 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897245
Page 49 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897246
Page 50 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897247
Page 51 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897248
Page 52 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897249
Page 53 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897250
Page 54 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897251
Page 55 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessme
ntArterial Blood Gases Pa
O2FiO2 (Fraction of Inhaled Oxyg
en)Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897252
Page 56 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Applicable
[ ]Comments
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897253
Page 57 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart Dat
eForm Instan
ce
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicab
le Not Appli
cable Repeating
Pages
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897254
Page 58 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897255
Page 59 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897256
Page 60 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897257
Page 61 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/24/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897258
Page 62 of 382
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Feb/24/2021Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/24/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR864L]
5.bSample ID [BSH3TH]
5.cSample ID [BSH3TJ]
5.dSample ID [BSH3TK]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897259
Page 63 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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:
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897260
Page 64 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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 [ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897261
Page 65 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897262
Page 66 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897263
Page 67 of 382
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Ident
ifierAdverse Eve
ntStart DateIs the Adverse Event Stil
l OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  COVID-19 Il
lness Dec/28/2020 UN
K:UNK NO
End Date Time:
Jan/23/2021 UNK:UN
K
 Repeating
Pages
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897264
Page 68 of 382
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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)[COVID-19 Illness]
4.Start Date Time: Dec/28/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/23/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation
of existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897265
Page 69 of 382
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[COVID Illness]
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[2021156182]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897266
Page 70 of 382
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication
ErrorStart D
ateIs the medication error Sti
ll OngoingStudy Medication Erro
rs ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897267
Page 71 of 382
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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[ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897268
Page 72 of 382
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationStart
DateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897269
Page 73 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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: //
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897270
Page 74 of 382
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897271
Page 75 of 382
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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?
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897272
Page 76 of 382
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897273
Page 77 of 382
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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?
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897274
Page 78 of 382
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897275
Page 79 of 382
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897276
Page 80 of 382
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/11/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897277
Page 81 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897278
Page 82 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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:
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897279
Page 83 of 382
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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?
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897280
Page 84 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897281
Page 85 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897282
Page 86 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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: [ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897283
Page 87 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897284
Page 88 of 382
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897285
Page 89 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897286
Page 90 of 382
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897287
Page 91 of 382
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897288
Page 92 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897289
Page 93 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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/24/2021
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897290
Page 94 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897291
Page 95 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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/24/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897292
Page 96 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/24/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR864K]
5.bSample ID [BSH3TD]
5.cSample ID [BSH3TF]
5.dSample ID [BSH3TG]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897293
Page 97 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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/24/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6L7S]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897294
Page 98 of 382
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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/24/2021 10:34
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897295
Page 99 of 382
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897296
Page 100 of 382
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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 [ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897297
Page 101 of 382
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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?
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897298
Page 102 of 382
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897299
Page 103 of 382
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897300
Page 104 of 382
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897301
Page 105 of 382
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897302
Page 106 of 382
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897303
Page 107 of 382
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897304
Page 108 of 382
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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: [ ]
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897305
Page 109 of 382
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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 Nov/11/2020
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897306
Page 110 of 382
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 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
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897307
Page 111 of 382
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897308
Page 112 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-23-2020 16:22:45 (UTC-06:00)
Central Time (US & Canada)N/A
Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897309
Page 113 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-05-2021 10:49:01 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897310
Page 114 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-05-2021 10:49:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897311
Page 115 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-05-2021 10:49:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897312
Page 116 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-05-2021 10:49:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897313
Page 117 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-05-2021 10:49:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897314
Page 118 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Feb-05-2021 10:49:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897315
Page 119 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Feb-05-2021 10:49:01 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897316
Page 120 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-05-2021 10:49:52 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897317
Page 121 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-05-2021 10:49:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897318
Page 122 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-05-2021 10:49:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897319
Page 123 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-05-2021 10:49:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897320
Page 124 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-05-2021 10:49:52 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897321
Page 125 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-05-2021 10:50:04 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897322
Page 126 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897323
Page 127 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897324
Page 128 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897325
Page 129 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897326
Page 130 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897327
Page 131 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897328
Page 132 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897329
Page 133 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897330
Page 134 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897331
Page 135 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897332
Page 136 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897333
Page 137 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897334
Page 138 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897335
Page 139 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897336
Page 140 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897337
Page 141 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897338
Page 142 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897339
Page 143 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897340
Page 144 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897341
Page 145 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897342
Page 146 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897343
Page 147 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897344
Page 148 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897345
Page 149 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897346
Page 150 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897347
Page 151 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897348
Page 152 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897349
Page 153 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897350
Page 154 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897351
Page 155 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897352
Page 156 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897353
Page 157 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-05-2021 10:50:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897354
Page 158 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-05-2021 10:50:18 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897355
Page 159 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897356
Page 160 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897357
Page 161 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897358
Page 162 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897359
Page 163 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897360
Page 164 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897361
Page 165 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897362
Page 166 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897363
Page 167 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897364
Page 168 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897365
Page 169 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897366
Page 170 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897367
Page 171 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897368
Page 172 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897369
Page 173 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897370
Page 174 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897371
Page 175 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897372
Page 176 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897373
Page 177 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897374
Page 178 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897375
Page 179 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897376
Page 180 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897377
Page 181 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897378
Page 182 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.eFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897379
Page 183 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897380
Page 184 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897381
Page 185 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897382
Page 186 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.fFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897383
Page 187 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897384
Page 188 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897385
Page 189 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897386
Page 190 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.gFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897387
Page 191 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.hFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897388
Page 192 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.hFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897389
Page 193 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.hFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897390
Page 194 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.hFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897391
Page 195 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897392
Page 196 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897393
Page 197 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897394
Page 198 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.iFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897395
Page 199 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897396
Page 200 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897397
Page 201 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897398
Page 202 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology - Comments
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.jFeb-05-2021 10:50:18 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897399
Page 203 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-05-2021 10:50:36 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897400
Page 204 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-05-2021 10:50:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897401
Page 205 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aFeb-05-2021 10:50:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897402
Page 206 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aFeb-05-2021 10:50:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897403
Page 207 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aFeb-05-2021 10:50:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897404
Page 208 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: VITAL SIGNS - COVID - Comments
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aFeb-05-2021 10:50:36 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897405
Page 209 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-05-2021 10:50:48 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897406
Page 210 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-05-2021 10:50:48 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897407
Page 211 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aFeb-05-2021 10:50:48 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897408
Page 212 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-05-2021 10:51:02 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897409
Page 213 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-05-2021 10:51:02 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897410
Page 214 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-05-2021 10:51:02 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897411
Page 215 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-05-2021 10:51:02 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897412
Page 216 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-05-2021 10:51:13 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897413
Page 217 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-05-2021 10:51:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897414
Page 218 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-05-2021 10:51:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897415
Page 219 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-05-2021 10:51:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897416
Page 220 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-05-2021 10:51:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897417
Page 221 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Feb-05-2021 10:51:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897418
Page 222 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Feb-05-2021 10:51:13 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897419
Page 223 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-05-2021 10:51:25 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897420
Page 224 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-05-2021 10:51:25 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897421
Page 225 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-05-2021 10:51:25 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897422
Page 226 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-05-2021 10:51:25 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897423
Page 227 of 382
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Dec/29/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Not Verified, Frozen
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-05-2021 10:51:25 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897424
Page 228 of 382
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-24-2021 11:50:21 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897425
Page 229 of 382
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-05-2021 10:43:04 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-13-2020 16:28:18 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-11-2020 15:55:07 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-10-2020 13:57:14 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897426
Page 230 of 382
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897427
Page 231 of 382
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-23-2020 16:21:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-23-2020 16:21:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897428
Page 232 of 382
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-23-2020 16:21:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obta
ined
Sep/23/2020Initial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897429
Page 233 of 382
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-23-2020 16:21:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10191226Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-23-2020 16:21:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1973Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-23-2020 16:22:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-23-2020 16:22:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-23-2020 16:22:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897430
Page 234 of 382
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-23-2020 16:22:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897431
Page 235 of 382
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-23-2020 16:23:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-23-2020 16:23:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-23-2020 16:23:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897432
Page 236 of 382
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-23-2020 16:24:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical Histor
y Term:Glaucoma
Start Date: UNK/UNK
/2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-23-2020 16:24:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 16:24:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
GlaucomaInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-23-2020 16:24:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897433
Page 237 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-23-2020 16:24:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-23-2020 16:25:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Myopia
Start Date: UNK/UNK/
1987
Ongoing: YESInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897434
Page 238 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-23-2020 16:25:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 16:25:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MyopiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-23-2020 16:25:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1987Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-23-2020 16:25:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-23-2020 16:25:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical Histor
y Term:PresbyopiaInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897435
Page 239 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK
/2000
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-23-2020 16:25:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 16:25:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PresbyopiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-23-2020 16:25:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-23-2020 16:25:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-23-2020 16:25:58
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb 4Initial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897436
Page 240 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) er:
Medical Histor
y Term:Heartburn
Start Date: UNK/UNK
/2018
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-23-2020 16:25:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 16:25:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HeartburnInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-23-2020 16:25:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-23-2020 16:25:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897437
Page 241 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-23-2020 16:26:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical Histor
y Term:Obesity
Start Date: UNK/UNK
/1994
Ongoing: YESInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897438
Page 242 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Sep-23-2020 16:26:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 16:26:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ObesityInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-23-2020 16:26:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1994Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-23-2020 16:26:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-23-2020 16:26:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Histo
ry Term:Nephrolithias
isInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
 
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897439
Page 243 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/1
991
Ongoing: NO
End Date:
UNK/UN
K/1991
1.f Line/MH Number:
Date Location User Value Reason
Sep-23-2020 16:26:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 16:26:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NephrolithiasisInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-23-2020 16:26:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1991Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-23-2020 16:26:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1991Initial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897440
Page 244 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g
Date Location User Value Reason
Sep-23-2020 16:27:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Histo
ry Term:Herpes zoster
Start Date: UNK/UNK/2
018
Ongoing: NO
End Date:
UNK/UN
K/2018Initial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897441
Page 245 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Sep-23-2020 16:27:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 16:27:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Herpes zosterInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-23-2020 16:27:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-23-2020 16:27:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.h
Date Location User Value Reason
Sep-23-2020 16:27:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8Initial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897442
Page 246 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical Histo
ry Term:Intermittent le
g cramps
Start Date: UNK/UNK/2
010
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Sep-23-2020 16:27:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 16:27:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Intermittent leg crampsInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-23-2020 16:27:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-23-2020 16:27:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897443
Page 247 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-23-2020 16:28:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9
Medical Histor
y Term:Recurrent ba
ck pain
Start Date: UNK/UNK/
1991
Ongoing: YESInitial Entry
1.i Line/MH Number:
Date Location User Value Reason
Sep-23-2020 16:28:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 16:28:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Recurrent back painInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-23-2020 16:28:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1991Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-23-2020 16:28:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897444
Page 248 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j
Date Location User Value Reason
Sep-23-2020 16:28:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:10
Medical Histor
y Term:Allergic rhi
nitis
Start Date: UNK/UNK
/1990
Ongoing: YESInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0897445
Page 249 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j Line/MH Number:
Date Location User Value Reason
Sep-23-2020 16:28:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 16:28:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Allergic rhinitisInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-23-2020 16:28:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-23-2020 16:28:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897446
Page 250 of 382
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-23-2020 16:29:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known t
o be HIV POSITIVEInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897447
Page 251 of 382
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-23-2020 16:30:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-23-2020 16:30:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
229.9Initial Entry
3. Unit:
Date Location User Value Reason
Sep-23-2020 16:30:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-23-2020 16:30:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
66.5Initial Entry
5. Unit:
Date Location User Value Reason
Sep-23-2020 16:30:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897448
Page 252 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-23-2020 16:30:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
36.5Initial Entry
7.a
Date Location User Value Reason
Sep-23-2020 16:30:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.6
Temperature Unit: F
Temperature Locatio
n::EA
RInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-23-2020 16:30:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-23-2020 16:30:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-23-2020 16:30:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897449
Page 253 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-23-2020 16:30:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EARInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897450
Page 254 of 382
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-23-2020 16:30:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-23-2020 16:30:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97847Initial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897451
Page 255 of 382
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020 16:31:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 16:31:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020 06:58:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-24-2020 04:45:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-23-2020 16:31:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897452
Page 256 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
appropriate.
Sep-23-2020 16:31:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020
06:58:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP98GPInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020
06:58:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP98GPInitial Entry
5.b
Date Location User Value Reason
Sep-24-2020
06:59:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRWTWInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897453
Page 257 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Sample ID
Date Location User Value Reason
Sep-24-2020
06:59:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRWTWInitial Entry
5.c
Date Location User Value Reason
Sep-24-2020
06:59:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRWTXInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-24-2020
06:59:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRWTXInitial Entry
5.d
Date Location User Value Reason
Sep-24-2020
06:59:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRWTYInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897454
Page 258 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Sep-24-2020
06:59:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRWTYInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897455
Page 259 of 382
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020 16:31:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 16:31:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-24-2020 06:59:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-24-2020 04:45:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-23-2020 16:31:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897456
Page 260 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
appropriate.
Sep-23-2020 16:31:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020
06:59:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP98MRInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020
06:59:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP98MRInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897457
Page 261 of 382
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-23-2020 16:32:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020 16:32:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020 16:32:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-23-2020 16:32:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020 12:54Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-23-2020 16:32:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897458
Page 262 of 382
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-23-2020 16:32:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-23-2020 16:32:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-23-2020 16:32:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-23-2020 16:32:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897459
Page 263 of 382
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-29-2020
01:21:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Closed by DM:
Sep-28-2020
08:54:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Sep-28-2020
08:54:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICIT
Y E-DIARY NOT COLL
ECTED FOR THIS SUBJ
ECTTranscription
Error
Sep-25-2020
08:34:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened eDiary: Per Trial
Max, Subject is
not the subset of
'Reactogenicity
Diary collection'.
Please review and
consider to update
response for
'Reactogenicity
diary collection' as
'No', else clarify in
query response.
Thanks
Sep-23-2020
16:32:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICI
TY E-DIARY COLLECT
ED FOR THIS SUBJECTInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897460
Page 264 of 382
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-14-2020 13:58:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897461
Page 265 of 382
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-14-2020 13:59:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
2.a
Date Location User Value Reason
Oct-14-2020 13:59:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 99.1
Temperature Unit: F
Temperature Locatio
n::EA
RInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-14-2020 13:59:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-14-2020 13:59:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
99.1Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897462
Page 266 of 382
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-14-2020 13:59:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-14-2020 13:59:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EARInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897463
Page 267 of 382
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 16:57:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 16:57:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020
16:58:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-15-2020
16:57:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-15-2020
16:57:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/14/2020Initial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897464
Page 268 of 382
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Oct-15-2020
16:58:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP98SPInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020
16:58:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP98SPInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897465
Page 269 of 382
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-14-2020 14:01:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-14-2020 14:01:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-14-2020 14:01:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-14-2020 14:01:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020 12:33Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-14-2020 14:01:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897466
Page 270 of 382
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-14-2020 14:01:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-14-2020 14:01:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-14-2020 14:01:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-14-2020 14:01:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0897467
Page 271 of 382
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-11-2020
15:55:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/11/2020Initial Entry
090177e196ae3e2c\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0897468
Page 272 of 382
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191226 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-11-2020 15:55:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-11-2020 15:55:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-11-2020
15:55:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-11-2020
15:55:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, howev
…[truncated]